Chapter 12: Pharmacy and Therapeutics Committee

After completing this chapter, the reader will be able to

• Describe the pharmacy and therapeutics (P&T) committee.

• Define the functions of the P&T committee.

• Describe attributes and structure of a P&T committee likely to promote its ability to function successfully.

• Describe where and how the P&T committee fits into the organizational structure of a health care institution or other groups.

• Describe how the pharmacy department participates in P&T committee activities.

• Describe and explain the concepts of drug formularies and drug formulary systems, and how pharmacy participates in their establishment and maintenance.

• Describe how P&T committee activities contribute to the quality improvement of medication use.

• Describe how to develop policies and procedures for the process of medication use.

1. A pharmacy and therapeutics (P&T) committee, or its equivalent, oversees all aspects of medication use within an institution.

2. Although it is common for pharmacists to downplay or misunderstand the importance of P&T committee support in comparison to other clinical activities, such support is vital for pharmacy to impact patient care.

3. A P&T committee may find it necessary to create ad hoc committees to address various issues, depending on their complexity and size.

4. Typically, P&T committee functions include determining what drugs are available, who can prescribe specific drugs, policies and procedures regarding drug use (including pharmacy policies and procedures, clinical protocols, standard order sets, and clinical guidelines), performance improvement as well as quality assurance activities (e.g., drug utilization review/drug usage evaluation/medication usage evaluation, as well as compliance surveillance), adverse drug reactions/medication errors, dealing with product shortages, and education in drug use.

5. A variety of topics regarding the quality of medication use, inclusive of applicable medication metrics, are normally part of the activities of a P&T committee.

When considering how a pharmacist can have an impact on a patient’s drug therapy, it is common to consider the individual practitioner dealing with a specific patient or, perhaps, a small group of patients. Certainly the clinician can have a deep impact this way, but it does have the disadvantage of dealing with a very limited number of patients. In order for pharmacists to efficiently impact a population of patients, a different approach is necessary. Fortunately, pharmacists have the opportunity to participate in the activities of ❶ a P&T committee or its equivalent, which generally oversees all aspects of medication use in an institution. Physicians and pharmacists have collaborated to implement cost-effective prescribing practices and assess clinical outcomes through educational initiatives, administrative programs to restrict ordering practices, use of formularies and prescribing guidelines, and financial incentives.¹ There are data to show that P&T committee actions are useful.^2,3

Before proceeding, it must be stated that while this chapter deals with the P&T committee, which is usually the group responsible for overseeing all aspects of drug therapy in an institution, there is sometimes a similar body referred to as the formulary committee. This latter group deals strictly with determining which drugs are carried within an institution or organization, whereas the P&T committee has numerous other tasks, covering all aspects of drug therapy (e.g., adverse drug reaction [ADR]/medication error monitoring, quality assurance, policy and procedure approval), although the exact group of functions may vary from place to place.⁴ Some institutions use a formulary committee, since other bodies may perform the additional P&T committee tasks described later in this chapter. Also, some health care groups may use both committees, with one body addressing the issues for the group as a whole, while the other is located separately at various institutions to address issues specific to that location (e.g., only one institution in the group has an oncology unit, therefore, the committee for that individual institution will consider specific antineoplastic agents that are not of much use for the rest of the group). In this chapter, anything discussed regarding which drugs are available within an institution or group applies to both bodies, whereas all other items are for the P&T committee only.

It should be noted that while P&T committees have normally been associated with institutional pharmacy, other organizations have increasingly used P&T-type committees in an attempt to improve drug therapy while lowering costs. Some places where such committees are seen include managed care organizations (MCOs),⁵ insurance companies, pharmacy benefit management (PBM) companies, unions, employers,⁶ state Medicaid boards, state departments of public institutions,⁷ Medicare,⁸ long-term care facilities,⁹ ambulatory clinics,¹⁰ and even community pharmacies.¹¹ Much of this chapter will use examples from institutional pharmacy and managed care, simply because much of the published literature deals with those areas of practice and it is the most likely setting in which a pharmacist will be directly involved in P&T committee activities. However, the concepts covered are applicable to any P&T-type committee and comply with recommendations of the American Medical Association (AMA),^12,13 the American Society of Health-System Pharmacists (ASHP),¹⁴ The Joint Commission (formerly the Joint Commission for the Accreditation of Health Care Organizations) (TJC),¹⁵ and the Academy of Managed Care Pharmacy (AMCP).¹⁶

The role of the P&T committee has been continuously expanded over the years and now encompasses a great number of functions and activities that cover all aspects of overseeing drug therapy. As some of these are of sufficient size and importance, they are covered separately in other chapters (e.g., drug monographs and quality assurance). In addition, there are a number of areas (e.g., investigational drugs) in which P&T committees play a secondary role, and these too are covered in other chapters. This chapter will serve to provide a base to tie together discussion of all of these areas and a number of smaller functions or activities that will be covered as a portion of this chapter. The information is appropriate both for those just learning about the concepts and also for those individuals who are involved with P&T committee activities.

The concept of a P&T committee represents a unique niche within the structure of a hospital or hospital system. The current role of a hospital in Western countries¹⁷ began about 200 years ago, at a time when very few efficacious medications were available, although drug formularies had been developed during the Revolutionary War to list the drugs available.¹⁸ It has also been noted that a drug formulary was developed for all municipal hospitals in New York City at Bellevue Hospital in 1868.¹⁹ Drug formularies were required for participation in the Medicare program in 1965.²⁰ The original hospital was a place to receive basic health care when a person had no extended family to provide the basic needs of good health. After infection control became a recognized concept and anesthesia for surgery evolved around 1900, the value of the modern hospital progressively became a recognized need for all segments of society. The origins for standards of how a hospital functioned subsequently developed during the first half of the twentieth century. This began with the early efforts of the American College of Surgeons in the United States (U.S.) to develop the first accreditation standards for hospitals. Later, the Joint Commission on Accreditation of Hospitals (JCAH), now known as TJC, evolved to centralize the basic requirements for the functional character of a U.S. hospital. The concept of the P&T committee originated and evolved to help hospitals meet various standards regarding drug therapy. The first P&T committee was formed at Bellevue Hospital in New York City in the mid-1930s.^18,21 While it dealt with true compounding formulas, it was originally founded to ensure quality and efficacy of those products, which is still a portion of the functions of P&T committees.

In keeping with the social origins of the hospital, the legally sanctioned or licensed privilege of being a professional health care provider evolved.¹⁷ Both the physician and pharmacist were considered unique for the needs of society. Minimum standards evolved, including the accreditation of their training as a basis for being licensed. Originally, physicians and pharmacists functioned primarily as independent professionals. The nature of a physician’s independence was legally defined to further support their obligations to a patient. Many states in the United States legally prohibited a physician from being employed by a corporation. Eventually, these laws were all repealed, but they had the effect of creating the basis for a medical staff as being a separate legal entity within a hospital. The medical staff reflected the legally evolving traditions of a physician, and indirectly the pharmacist, as being independent professionals committed only to the care of a patient without unnecessary outside influences. This evolution has had a major impact on the organizational structure of hospitals.

A typical hospital organization is shown in Figure 12–1. The board of directors divides the functions of its organization into two entities. First, the administration of the hospital operates as a typical business with a chief executive officer, chief operating officer, and so forth. Second, the board of directors authorizes that a medical staff be formed that reports separately to the board of directors. While the medical staff as a whole is ultimately in charge of all clinical aspects of care in the hospital, in most institutions this is unworkable without an administrative structure of some kind. Therefore, the medical staff may elect officers and either elect or appoint somebody to oversee all aspects of patient care. In this example, the term medical executive committee is used for that body, although the name and exact function may vary. The medical staff functions to certify the credentials of its members, establish their scope of practice where appropriate, monitor the quality of health care provided by its members, and maintain the means to collaborate with the administration of the hospital.

In modern medicine, there are so many clinical areas to consider that it is unrealistic for one committee to adequately oversee all aspects of patient care, except in very small institutions. For this reason, various subcommittees of the medical executive committee are usually necessary, as can be seen in Figure 12–1. As a means to coordinate the needs of the medical staff and the operation of the hospital pharmacy, the modern P&T committee developed. From the traditions established by TJC and ASHP, the P&T committee developed as a function of the medical staff’s responsibilities. This committee or related committees may have other names, such as the drug and therapeutics committee in other countries,^22,23 but the functions are the same. While the P&T committee has been referred to in TJC accreditation standards in the past, it is no longer specifically required and may be replaced by some other committee or body,^15,24,25 although the P&T committee concept is supported by many national and professional organizations.²⁶ Given the continuing growth in the number, complexity, and expense of medications, both the importance and number of functions of the P&T committee have continued to increase. Policy and procedures to set up a P&T committee are described in Appendix 12–1, but the following will serve as a general description of P&T committees and their actions.

In some cases, the P&T committee may be part of a corporation of hospitals and medical centers, rather than just being for a specific institution. While the philosophy of operating one P&T committee within this corporate structure seems reasonable, this is not often accomplished without problems and decentralization of these efforts may be better.²⁷ Different patient populations, medication needs, cross hospital physician participation, meeting time, length and location of meetings, and differing clinical cultures within a specific institution are examples of barriers that may be present. The P&T model may need to be revised to work with these challenges.^28-33

Although it is easy to assume from its name that the P&T committee is organizationally a part of the pharmacy department, such is not the case, as was mentioned above. Instead, it is usually a medical staff entity and, perhaps, only one or two pharmacists may actually be members of the committee (possibly ex officio members without voting privileges). Commonly, the pharmacy director or clinical coordinator, serving as the committee’s secretary (e.g., taking minutes, collating, and arranging the agenda), may be the sole official pharmacy representative. Other pharmacists may also attend to act as consultants to the committee, often having great impact on the committee’s decisions, even if they cannot officially vote. Fortunately, in larger hospitals, it appears that more pharmacists are now becoming full members of the P&T committee.³⁴

Typically, the voting members of an institutional P&T committee are limited to members of the medical staff, although there may be a few voting or nonvoting members from other groups, including pharmacy. Membership is mostly physicians (preferably a wide variety of physicians from various areas of practice), but usually includes at least one pharmacist and often members from other areas of the hospital (e.g., nursing, administration, radiology, respiratory therapy, dietary, quality assurance, medical records, laboratory, and risk management).³⁵ A pharmacoeconomist also can be extremely helpful. There have also been recommendations to include other individuals, such as a medical ethicist or community pharmacist.³⁶ It may be best to try to keep down the number of physician members to encourage a smaller group to participate more fully, while taking care of addressing the wide variety of issues by calling in physicians to consult with the committee on an as needed basis.³⁷ In some cases, the pharmacy department is asked to recommend physicians for the committee. If possible, pharmacy should suggest physicians who are noted for their commitment to rational drug therapy.³⁸ As an example, the U.S. Department of Defense has procedures for appointment of members, including nonphysician members, of the P&T committee. The procedures are available on the Internet.³⁹ Also, efforts should be made to ensure that the physician chosen to be chairman of the committee is an advocate of the pharmacy department. It is possible for the medical executive committee of the medical staff to pass a resolution to approve a policy broadening the voting members of the P&T committee (e.g., director of pharmacy or hospital vice president) or delegating the functions of the P&T committee to the hospital. In this latter arrangement, the medical staff would reserve the right to terminate the policy if the P&T committee fails to support the needs of the medical staff. If the P&T committee is a hospital committee, rather than medical staff committee, a pharmacist or nurse might more easily obtain voting privileges, given appropriate physician quorum requirements in the authorizing policy.

The P&T committee of MCOs and government bodies often have similar membership to that in institutional committees; however, there may need to be a requirement for at least some of the members to be independent practitioners and retail pharmacists (i.e., having no financial ties to the organization or group that sponsors the P&T committee).^35,40,41 In accordance with the 2003 Medication Modernization Act, the use of formularies is an essential component to the PBM.³⁵

Once the general organizational setting of the P&T committee has been determined, the operating policy of the P&T committee requires careful attention to two key issues. The first key issue is obvious—to whom does the P&T committee report and to what degree can the decisions of the P&T committee be overturned by another segment of the organization? It is important to point out that the P&T committee may act only as an advisory body to the medical executive committee. Decisions of the P&T committee may not be considered final (and, therefore, not be implemented) until they are reviewed and approved by the medical executive committee. In this situation, a report is forwarded from the P&T committee after each meeting to the medical executive committee. In addition, an annual report of the P&T committee may be prepared for both internal review and review by the medical executive committee. This annual report is time consuming in preparation, but is a very important means of tracking P&T activities and action over time.

The second issue is that the P&T committee will likely be successful based on the leadership qualities of its members and the chairperson. The role of the chairperson includes developing the respect and involvement of all members of the committee.

PHARMACY BENEFIT MANAGEMENT (PBM) P&T COMMITTEE ORIGIN

The origin of the PBM organizations dates back to the late 1960s. Their primary focus was on claims administration for insurance companies. Later, it became a challenge for the insurance companies to efficiently manage the increase in drug coverage in the private sector when the prescription volume was high and the cost per claim was low.⁴² The plastic drug benefit card began in the 1970s and changed the way many prescriptions were bought and paid for by the insurance company and employee. From then on, any employee with an ID card, using a pharmacy network, only had a small copayment.⁴² In addition, administrative costs for the third-party payer, whether it is the insurance company, health plan, or employer, were reduced, with the PBM creating pharmacy networks and mail service benefits. Pharmacy networks are a group of pharmacies that are under contract with the insurance company, health plan, and/or their contracted PBM partner to promote prescription services at a negotiated discounted fee.⁴³ Mail service is a program offered by the PBM, whereby pharmaceutical agents, both prescription and nonprescription, are offered through the mail.⁴³

In the late 1980s, the introduction of real-time electronic claims processing began. Not only was there two-way communication between the pharmacy and the PBM for claim processing, but also for clinical information. In the 1990s, the PBMs moved toward a greater emphasis on patient health by offering a variety of new services in addition to the claims processing. Since 2000, there has been an emphasis on consumer behavior modification, enhanced patient interventions, physician connectivity, clinical consulting, disease management, and retrospective drug utilization review (DUR; see Chapter 14 for further information) to name a few.⁴²

One of the key functions of a PBM is to design, implement, and administer outpatient drug benefit programs for employers, MCOs, and other third-party payers. PBMs manage prescription drug benefits separate from other health care services (i.e., physician and hospital services).⁴³ Determining which medications are most cost-effective, without compromising patient care, is one of the key elements for controlling the cost of a prescription drug benefit.^6,44 PBMs accomplish this by developing drug formularies.⁶ Formularies define what medications are covered (i.e., paid for) and provide the main component of the pharmacy benefit. Specific PBM drug payment and management activities occur within this formulary structure, such as therapeutic interchange and disease management programs. Eighty to one hundred percent of PBM-covered lives receive some type of formulary management service.^6,43 The use of drug formularies is in flux due to the advantages and disadvantages identified over the last decade or so; however, they are likely to be continued for at least the foreseeable future, particularly due to the Medicare drug formulary requirements.⁴⁵

Development and maintenance of drug formularies for third-party payers is an ongoing process. The formulary must be continuously updated to keep pace with new drugs, therapies, prices, recent clinical research, changes in medical practice, evidence-based treatment guidelines, and updated Food and Drug Administration (FDA) information.⁴⁶ PBMs use a panel of experts called the P&T committee to develop and manage their drug formularies. Many times individuals with special clinical expertise are consulted when considering medications within a specific therapeutic class.⁴⁶ Meetings are usually held on a quarterly basis, and not only are drug formulary recommendations made, but this group also provides input into other clinical areas, such as development of disease management programs.^{6,42,43,45,46}

Many PBMs establish their own P&T committee to evaluate the efficacy, safety, uniqueness, cost of therapeutic equivalent drugs, and other appropriate criteria. In addition, PBMs work with the health plan, employer, or insurance company P&T committee to develop drug formularies using the same evaluation process. In either case, if the P&T committee determines that one drug provides a clear medical benefit over the other, therapeutically equivalent drugs in that same therapeutic category, the drug is usually added to the formulary.⁶ However, if there are drugs in the same therapeutic category that have very similar efficacy and safety profiles and no unique properties that would make it a better drug, then the net cost becomes a deciding factor as to which drug should be added to the formulary.⁶ There has been some discussion as to whether drug costs are weighted too heavily, while drug efficacy and other clinical information is weighted too lightly when it comes to drug formulary decisions.^42,43 The committee leadership needs to recognize the potential for conflicts of interest between efficacy and economic interests of the PBM and to establish collaboration as the basis for resolving conflicts that arise.

Me-too drugs are drugs that are structurally very similar to an already known drug that has only minor differences. Many drugs come in two versions: an L-isomer (left) and an R-isomer (right). An example of a me-too drug is esomeprazole (Nexium^®), the L-isomer of omeprazole (Prilosec^®, the R- and L-isomers). Both drugs are used to treat gastroesophageal reflux disease (GERD). When a comparative analysis was conducted looking at drugs approved for marketing between January 2007 and July 2008, those that had a different chemical entity and a separate mechanism of action accounted for 69%; however, they offered no clinical improvement over those already on the market. Forty-four percent offered some type of new convenience, but only 13% offered greater efficacy.⁴⁷

In the case of a health plan, employer, or insurance company’s own P&T committee, the drug formulary recommendations made by the PBM P&T committee are presented and reviewed by the organization’s P&T committee. The PBM recommendations regarding drug formulary recommendations can be either accepted or denied by the organization’s P&T committee and the organization’s own decision made regarding formulary inclusion.

❷ Although it is not uncommon for pharmacists to downplay or misunderstand the importance of P&T committee support in comparison to other clinical activities, such support is vital for pharmacy to impact patient care. P&T committee support and participation can have far-reaching effects on the overall quality of drug therapy in an institution and must be given a great deal of attention, since the benefits of its function serves to build collaboration, transparency, and trust among the institutional divisions of authority for drug therapy within health care. While such attention is time consuming,⁴⁸ it can be of value to the pharmacy since this is an opportunity to present recommendations to a decision making body and P&T committees often accept pharmacy recommendations^49,50; therefore, pharmacy departments can have a great and far-reaching impact on drug therapy through this mechanism.

Some pharmacists who participate in P&T committee activities feel they are serving their function by just providing information requested by physicians and considering drugs for formulary approval only following physician requests. This can rapidly deteriorate into crisis management, where the pharmacy department reacts to problems, fighting each fire as it occurs. It is much better for a pharmacy to be proactive,^51,52 seeking to address issues (e.g., changes in drugs carried on the formulary, new policies and procedures, quality assurance activities, and so forth) before they become problems. TJC accreditation requirements include annual evaluation of all drugs and/or drug classes.¹⁵ Through prospective actions with the P&T committee it is possible for the pharmacy to get physician support for their clinical activities.

In the specific instance of P&T committee support, one or more pharmacists must be identified to conduct the necessary planning. This may consist of a pharmacy-based steering committee and might include administrators, purchasing agents, or clinicians, and, particularly, drug information specialists. These people must develop and regularly evaluate data sources to anticipate physicians’ needs⁵³ (see Table 12–1). For example, it is necessary to assess what drugs have been recently FDA approved in order to identify drugs for possible formulary inclusion. FDA approval often occurs about 3 months before commercial availability and is published on the FDA Web site (http://www.accessdata.fda.gov/scripts/cder/drugsatfda/index.cfm). Therefore, there is time for the drug to be considered for formulary addition before the first orders arrive from the nursing units, which necessitates a review of some sort under TJC standards.¹⁵ In a case where it is not possible to consider a drug before it is commercially available, it has been suggested by some that drugs rated P (priority) by the FDA be made available to physicians until the drug can be fully considered (the FDA classification codes are found in Tables 12–2 and 12–3, with the priority versus standard explanation found in Table 12–3).⁵⁴ This latter procedure may be effective, but considering the drug before commercial availability is preferable, because if the ultimate P&T committee decision is to leave the drug off the drug formulary, there may be difficulties in helping physicians stop the use of the product. It is also a good idea to track older drugs. For example, the use of nonformulary drugs may be tracked within the hospital (Note: a nonformulary drug may be a product that has not been approved for use within an institution, but may also be a drug that has been approved for use, but has been prescribed in a particular situation for a use other than what was approved by the P&T committee when it was added to the drug formulary).^55-57 If patterns of increased use are noted, it is best to identify a reason for that use. If the use is inappropriate, the physician(s) should be contacted and given information about alternative formulary agents. In some cases, new information may be available showing a new advantage or use for an old agent, which can lead to its reconsideration for formulary adoption. Related to this is the necessity to regularly consider the material being promoted by the drug company representatives. It is worth mentioning that some hospitals will restrict drug representative access to the institution or restrict the drugs that may be promoted by those representatives to only items approved for use in the hospital in order to prevent this problem (see Chapter 24 for further information). There may also be new indications or other information that will increase demand for nonformulary items. If there are sufficient changes noted in the use(s) of a particular class of drugs, it is useful to review the class as a whole to decide which drug(s) are to be retained on the formulary. TJC now requires annual review of all medications,^10-15 which is useful because there may be new information (e.g., labeling changes or safety in terms of postmarketing surveillance) not otherwise noted that necessitates changes in formulary items in a particular class, both additions and deletions. However, these situations that have been noted above may necessitate moving up the review. Other items, such as trends in reported ADRs in the institution or published data for new products with little information in the literature on first approval may also be useful in determining products for P&T committee consideration or reconsideration.⁵⁸ Although there must be a mechanism by which physicians can request that drugs be added to the formulary, all of the above methods and others can help the pharmacy anticipate physician needs, allowing time for information gathering, evaluation of products, and P&T committee consideration before the need becomes too urgent to permit proper consideration.

To guide the clinician into considering the logic of requesting the addition of items to the drug formulary, a specific request form may be useful. Items that a physician may be required to fill out or attach to the form can be seen listed in Table 12–4.⁵⁹ An example form is seen in Appendix 12–2.

The P&T committee should be kept advised by the above-mentioned pharmacy-based steering committee of future plans, so that it can be aware that a rational planning process is governing its agenda. Also, it is a good idea for one or more representative(s) of this steering committee to meet with the pharmacy director, chairman of the P&T committee, and a representative of the hospital administration on a regular basis to assist with planning and ensure their concerns are addressed. This meeting could be held shortly before the P&T committee actually meets to present preliminary formulary evaluations, DUE material, and policy and procedure documents for an initial review, allowing modifications addressing physician and administration concerns to be made before formal committee review and action. During this meeting, plans for future months can be made or adjusted as the circumstances dictate. Other appropriate physicians or groups should also be consulted in order to ensure that their concerns are addressed. For example, if changes to the cephalosporins carried on the drug formulary or their permitted uses (e.g., restrictions to particular uses or prescribing groups) are considered, the infectious disease specialists should be contacted to provide input. (Note: This does not necessarily mean that recommendations are changed to account for physician preferences, but that their preferences and concerns are specifically addressed in the evaluation.)

Regarding quality assurance activities, the pharmacy department should obtain data to guide the selection of upcoming quality assurance programs. This will be covered in greater detail in Chapter 14.

The pharmacy should also investigate which medications need specific policies and procedures developed to guide their use and monitoring. This may be done when the drug is first being evaluated for formulary addition or later if problems (e.g., increased ADR reports, medication errors, and overuse) are noted. For example, concerns about a new thrombolytic agent leading to increased morbidity and mortality through improper use might prompt the P&T committee to approve specific protocols for the use of the agent. Policy and procedure documents are covered later in the chapter. Information on preparing policies and procedures can be found in Chapter 18.

Finally, it is extremely important for the P&T committee to make sure that physicians are informed about the actions taken. Often the pharmacy is heavily involved in providing this information to physicians. While a great deal of effort is placed on communication within the committee itself, it is also necessary to keep the entire medical staff informed. This may be accomplished through medical department meeting presentations, newsletters and Web sites (refer to Chapter 9), or other mechanisms.

AD HOC COMMITTEES

❸ A P&T committee may find it necessary to create ad hoc committees to address various issues, depending on their complexity and size. Some of the common committees are discussed below. Institutions may or may not use these committees (sometimes referred to as subcommittees) and their exact use varies from place to place, depending on their needs or desires.⁴

Adverse Reactions

A comprehensive ADR monitoring and reporting program is an essential component of the P&T committee (see Chapter 15 for further information about ADRs and how they are handled). A subcommittee may be helpful to review the entire ADR data for trends and any necessary actions that need to be taken. The P&T committee will usually report the ADR data on a monthly or quarterly basis. Following approval of this report, the P&T committee is responsible for the dissemination of information to the medical staff and other health professionals in the institution. This includes recommending processes to cut the rate of preventable ADRs. This subcommittee may be combined with the medication errors subcommittee.^15,60

Anticoagulation

The anticoagulation subcommittee is responsible for policies and procedures to maintain compliance with TJC Goal 3E, now called the TJC National Patient Safety Goal 03.05.01.¹⁵ This goal is to reduce the likelihood of patient harm associated with anticoagulation therapy. The subcommittee can also participate in improvement processes to maintain standards with quality organizations such as the National Quality Forum (NQF), and the Surgical Care Improvement Project (SCIP). Standard orders and policies to follow evidence-based guidelines of the American College of Chest Physicians (ACCP) are also developed by this subcommittee. Pharmacists have an important role on this committee. Most hospitals have pharmacists dedicated to anticoagulation monitoring and education.

Antimicrobials/Infectious Disease

Antibiotics can represent the largest category of formulary medications.⁶¹ Frequent category review and revision is necessary and complex.⁶² Cunha has defined five factors to consider when reviewing antimicrobial agents for formulary inclusion: microbiologic activity,⁶³ pharmacokinetics and pharmacodynamics profiles,⁶⁴ resistance patterns,^65,66 adverse effects,⁶⁷ and cost to the institution.⁶⁸ The P&T committee or a subcommittee of the P&T may be responsible for developing appropriate antibiotic selection and use in both inpatient and outpatient settings.^69,70 Some institutions may rely on input from the infection control committee regarding antibiotic formulary management and appropriate utilization. Multidisciplinary antibiotic use committees have limited inappropriate prescribing of antimicrobials and increased the medical staff’s knowledge on appropriate antibiotic use.^68,71,72

The main purpose of the antimicrobial/infectious disease subcommittee is to promote antimicrobial stewardship to ensure cost-effective therapy and improve patient outcomes. Antimicrobial stewardship promotes and optimizes antimicrobial therapy consistent with the hospital’s/health system’s antibiograms. Guideline development and education is provided to the medical staff as well as to other health care professionals. The subcommittee is also involved in the enforcement of formulary agent use, substitution policies, and restrictions for antibiotics. In addition, review and feedback on prescribing patterns is provided to the medical staff regarding antibiotic therapy.^73-75 Use of P&T formulary and policy decisions has been shown to be successful in controlling antimicrobial use in hospitals.^76,77

Medication Safety

A medication safety committee (sometimes called safety committee or medication misadventure subcommittee) should be multidisciplinary in nature. This subcommittee will review medication misadventures and medication errors that occur within the institution or health care system. They may also review adverse drug reactions (instead of an adverse reaction committee), drug–drug interactions, drug dispensing processes, medication errors (see Chapter 16 for more information), look-alike/sound-alike medications, and communication errors. It may also be appropriate for them to review protocols to improve medication safety, such as the settings for intravenous fluid pumps. A report will commonly be presented to the P&T committee on a quarterly or semiannual basis. Following approval of this report, the P&T committee is responsible for the dissemination of information to the medical staff and other health professionals in the institution. This includes recommending processes to cut the rate of preventable medication safety issues. In some places, a medication error reduction plan (MERP) is prepared to identify process improvements that have been made and those that are planned. When evaluating drug cost strategies, patient safety should always be a priority.⁷⁸ The 2013 Joint Commission Accreditation Process Guide for Hospitals addresses the potential for adverse drug events.¹⁵ Also, as will be explained in the next chapter, patient safety will be evaluated whenever a product is considered for formulary addition.

Medical Devices

The P&T committee or a subcommittee may be responsible for the approval of some medical devices within an institution. This subcommittee is often multidisciplinary and is given the opportunity to review medical devices before purchases are made or contracts are signed. The committee is also responsible for reviewing the safety information associated with these devices because adverse medical device events are an important patient safety issue. Devices that contain medications, such as topical hemostats that contain thrombin, may also be reviewed by the committee or by the transfusion service committee described below.

Nutrition

As nutrition of the hospitalized patient evolved and became more complex, the role of the pharmacist on a nutrition support team became more justified. Their role started out improving the ordering process for parenteral nutrition, and communicating these changes to the pharmacy staff for proper preparation. Today, pharmacists on the nutritional team assist in the clinical management of parenteral nutrition patients, parenteral nutrition research, and continual involvement with improving the safety of parenteral nutrition use.⁷⁹ TJC, in their National Patient Safety Goals (NPSG), once addressed the safe use of parenteral nutrition feeding solutions,⁸⁰ but even though that has been removed, one of the responsibilities of the P&T committee is to oversee and approve the components of the parenteral nutrition solutions.

Quality Assurance of Medication Use

A subcommittee of the P&T committee may be placed in charge of planning and overseeing the plan for quality assurance regarding drug therapy. Details about this activity are found in Chapter 14. This committee may develop criteria for a drug use evaluation, collect the data, interpret the data, and recommend acting when necessary regarding the appropriate use of medication.

Tranfusion Service Committee

Hospitals often have a transfusion service committee charged with reviewing the use of blood and blood derivative products. Many of these products overlap with medications and may also be classified as medications. Therefore, it is necessary for this type of committee to work with or, possibly, be combined with the P&T committee in order to oversee the proper use of such products.⁸¹

Many times departments or service lines (e.g., oncology, cardiology, psychiatry/mental health, radiology, anesthesiology, women’s health) are asked for input regarding the formulary management within their specialty area of practice.

P&T COMMITTEE MEETING

Before beginning the description of a typical P&T committee meeting, it is important to note that a smoothly functioning P&T committee has certain needs. The committee will need the support of its parent organization. A room for the meetings should be carefully selected (see Appendix 12–3). The agenda for the meeting should be prepared in advance by the committee’s secretary and sent to the members. Most often, as mentioned previously, an informal meeting of the supporting pharmacists and others is required between P&T committee meetings to plan the activities necessary to support the agenda. The chair of the committee may also attend such planning meetings to ensure that priority issues are addressed before the meeting. Formulary reviews represent a special concern when sending out an agenda, since they may trigger the outside influences of dedicated pharmaceutical marketing efforts if companies learn from committee members that their products or their competitor’s products are being evaluated. Efforts must be made to make sure the committee is not distracted by outside influences, such as the pharmaceutical industry and advertisements. This consideration should be reflected in the selection of members and it may be necessary to avoid sending out some materials ahead of time, to lessen the chance of them being obtained by pharmaceutical company representatives. Also, if it is possible to prevent pharmaceutical representatives from knowing the membership of the committee, many of these problems may be avoided. If materials are sent out, it may be found that sending minutes from the previous P&T committee meeting is not always appropriate, since it may be difficult to adequately describe the full basis of a decision in a set of minutes. As a result, the minutes might be open to inappropriate projection regarding the basis for the P&T committee decision process. Some institutions simply make the minutes a pure recording of the decisions, eliminating any information about the discussion to avoid this problem. A sample set of minutes is seen in Appendix 12–4. Along with sending an agenda to members, a reminder phone call, fax, and/or e-mail may be useful to facilitate attendance. Each P&T committee meeting will require extensive preparation by the pharmacists involved in its affairs. Specifically, management of the formulary requires extensive background research and the preparation of written reports for any addition or deletion. Similarly, quality-related functions require time-consuming review of patient records. Finally, the P&T committee functions will be peripherally related to other affairs of the parent organization, for example, the standard order set preparation by other segments of a hospital. This requires special attention in order to prevent the use of nonformulary products. These items will be discussed in greater detail in the next section. Finally, the chairperson should be skilled at guiding an efficient meeting (see Appendix 12–5). In respect of the time commitment for members, meetings should always start and end at the scheduled times.

P&T Committee Functions

❹ Typically, P&T committee functions include determining what drugs are available, who can prescribe specific drugs, policies, and procedures regarding drug use (including pharmacy policies and procedures, clinical protocols, standard order sets, and clinical guidelines—see Chapter 7 for the latter), performance improvement as well as quality assurance activities (e.g., drug utilization review/drug usage evaluation/medication usage evaluation, as well as compliance surveillance—see Chapter 14), adverse drug reactions/ medication errors (see Chapters 15 and 16), dealing with product shortages, and education in drug use.^15,82,83 Many of those functions are related to quality assurance activities, because they are designed to improve the quality of drug therapy. Because the functions may improve drug therapy quality, they may actually provide some legal protection for an institution, as long as the reason for decisions is not strictly based on financial considerations.⁸⁴ P&T committee functions can also include investigational drug studies; however, that is often delegated to the Institutional Review Board (IRB) that oversees all investigational activities in the hospital (see Chapter 17). In addition, some P&T committee functions may be delegated to subcommittees (e.g., quality assurance, antibiotic, and medication errors subcommittees)⁸⁵; however, this can be cumbersome and is often avoided, except in larger institutions. P&T committees should recognize principles of epidemiology and pharmacoeconomics in the decision making whenever possible.^86-88 A standardized safety assessment tool has been developed to evaluate potential formulary agents.⁸⁹

According to TJC, the medical staff, pharmacy, nursing, administration, and others are to cooperate with each other in carrying out the previously mentioned functions.¹⁵ Although the medical staff normally takes overseeing drug therapy very seriously and expects to approve all activities of the P&T committee, it is common for the pharmacy department to do much of the preparation work for the committee. Although it is tempting to say the reason pharmacies are charged with all of the work is that they are the drug experts, which is usually true, it is probably more realistic that the reason is that pharmacists are paid to do this as part of their salary. Physicians usually do not obtain any direct monetary compensation for this committee’s work, although such compensation may be considered by an institution to encourage more physician participation.

FORMULARY MANAGEMENT

Drug Formulary

Wherever a drug formulary system is in place, there is usually a drug formulary published, as a hardcopy book and/or more commonly in electronic format (e.g., Web site, intranet, or other software). In its simplest form, the drug formulary contains a list of drugs that are available under that formulary system, which reflects the clinical judgment of the medical staff.^90,91 This list will be arranged alphabetically and/or by therapeutic class (American Hospital Formulary Service [AHFS] classification usually), and usually contains information on the dosage forms, strengths, names (e.g., generic, trade, and chemical), and ingredients of combination products. Many drug formulary publications contain a great deal more material related to the drugs, including a summary of indications, side effects, dosing, use restrictions, and other clinical information.⁹² Formularies may also be referred to as preferred medication lists or preferred drug lists.¹⁸

A related term, the formulary system, can be thought of as a method for developing the list, and sometimes even as a philosophy.⁹³ In theory, a well-designed drug formulary can guide clinicians to prescribe the safest and most effective agents for treating a particular medical problem, at the most reasonable cost.^94-99 Some people argue that the formulary system itself does not work because it is not properly implemented and recommend replacing it with counterdetailing by pharmacists or computers at the time a prescription order is written (see Chapter 23 for further information).¹⁰⁰ However, whether or not that is true has yet to be determined. The most well-known article indicating that formularies may ultimately result in higher patient costs was written by Horn and associates.¹⁰¹ While this may be one of the best articles on the topic and the author has defended criticism of the article,¹⁰² there are nevertheless various deficiencies in the study that make it uncertain whether it was truly the drug formulary or other factors that lead to increased costs.^103-106 Horn and associates¹⁰⁷ also published a similar study conducted in the ambulatory environment, which appears to have similar results and deficiencies. In the case of national drug formularies, there has been a positive¹⁰⁸ effect on prescribing habits shown in Canada. A study of formulary use in the western Pacific region found that they are commonly used in hospital, but questioned their effectiveness, since in that area the products on the formulary are often not connected to treatment guidelines or the best evidence for treating disease.¹⁰⁹ Further research is needed before a definite conclusion may be reached on the effectiveness of formulary management.¹¹⁰ For now, a well-constructed formulary is still believed to improve patient care while decreasing costs. It serves as a focus for building comprehensive drug therapy options.

The goal of the formulary system is to provide a decision-making process leading to the selection of medications necessary for the treatment of any disease states likely to be seen in that institution.⁹⁵ In some cases, decisions for formulary addition can be made for entire groups of institutions, for example, the U.S. Veteran’s Administration has combined the formularies of all of its component parts.¹¹¹ These formulary medications should be the most efficacious and cost-effective agents with the fewest side effects or drug interactions.¹⁵ Other factors should also be taken into consideration, such as the variety of dosage forms available for the medication, estimated use, convenience, dosing schedule, compliance, abuse potential, physician demand, ease of preparation, storage requirements, and risks.¹¹² Economic factors should not be the sole basis for this evidence-based process.⁹⁵ Typically, only two or, perhaps, three drugs from any drug class are added to the formulary. Some people would argue that only one agent is necessary from any class; however, some individuals will not respond and/or tolerate certain agents, so at least one secondary agent is usually desirable. Therapeutic redundancy must be minimized, however, by excluding superfluous or inferior preparations. This should improve the quality of prescribing and also lead to improved cost-effectiveness, both by eliminating less cost-effective agents that do not improve patient care and by assisting patients to become well faster. To analyze potentially conflicting literature and strength of recommendation, a grading system has been developed for review of potential formulary additions.¹¹³

Whether an institution has a very strict formulary with a minimum number of items or a less-restricted formulary that excludes items that are significantly inferior is sometimes a matter of philosophy. The former will cut down the pharmacy department’s inventory and often save money through avoidance of highly priced products, but may only be practical in closed health maintenance organizations (HMOs) where the same formulary is used in both the inpatient and ambulatory environments. In cases where physicians are free to prescribe whatever products they prefer in the ambulatory environment, they have been shown to have difficulty in remembering what products are contained on the formularies of third-party payers.¹¹⁴ Therefore, the increased time necessary for pharmacists to contact physicians for order changes may lead to the disruption of patient care. As a result, a less-restricted formulary may be more practical. As an example, a patient is admitted to the hospital on a nonformulary medication. While there would be other satisfactory medications in the same therapeutic category on the formulary, it may be best to simply allow use of the nonformulary product, rather than adding another complicating factor to the patient’s hospital treatment by attempting to change therapy. Pharmacist and physician time would also be saved.

Even in cases where an institution has a strict and enforced drug formulary, it should be noted that there are occasions when it is necessary to prescribe a drug that is not on the drug formulary. This might be due to a patient with a rare illness, a patient who does not respond or has intolerable side effects to the formulary drugs, a patient stabilized on a nonformulary medication where it would be difficult or dangerous to change, a conflict between the institutional formulary and the patient’s insurance company formulary,¹¹⁵ or some other valid reason. A mechanism must be in place to promptly obtain the particular drug when it is shown to be necessary (the National Committee for Quality Assurance [NCQA] requires such a mechanism for HMOs,¹¹⁶ as does TJC for other hospitals,¹⁵ but it must try to prevent physicians from ordering nonformulary drugs “because I said so!”). Some institutions require specific request forms to be filled out (see example in Appendix 12–2), sometimes with a cosignature from the physician’s department head, or at least require a consultation between a pharmacist and the physician before the drug is obtained. Also, patients may be charged more for the nonformulary medications. In some HMOs and insurance company plans, the physicians or pharmacies may be financially penalized for use or overuse of nonformulary medications.¹¹⁷ Whatever mechanism is used, it is important to make it easy to obtain necessary nonformulary medications, but difficult to obtain unnecessary medications, otherwise the benefits of the formulary system may be negated.⁵⁶ Also, it is necessary to track which nonformulary drugs are being used regularly and why that is happening because it may be worthwhile to add an agent to the drug formulary.¹¹⁸

Some physicians feel that a drug formulary serves only to keep costs down, at the expense of good patient care.¹¹⁹ These physicians must be reassured that there is evidence to support that a good formulary does keep expenses down¹²⁰ without negatively affecting care,¹²¹ although in some cases the costs are merely transferred to other hospital expenses.^122,123 One study demonstrated that a well-controlled formulary or therapeutic substitution (substituting a different medication that is effective for the disease being treated for the one ordered by the physician) results in 10.7% lower drug costs per patient day, and both a well-controlled formulary and therapeutic substitution together could cause 13.4% lower drug costs per day.¹²⁴ Some physicians do not like formularies because they consider them to be a limitation to their authority.¹¹⁹ It is necessary to keep in mind that when physicians become a part of a medical staff or sign up to participate in some managed care group they are given privileges not rights. The privileges generally do include limitations on what medications they can prescribe, and when and how they can prescribe them. If a drug formulary system is run well, there is little reason to feel there are inadequate drugs available; however, it does take some effort for the physician to learn to use the drugs available rather than the drugs they normally prescribe. An effort must be made to collaborate with physicians in this regard and to reassure them that every effort is being made to ensure the best drugs are available for the patients. Additionally, all changes to the drug formulary must be quickly and effectively communicated to the physicians to avoid confusion. A lack of such communication can negate some of the benefits of the formulary and lead to poor physician/pharmacist relations.¹²² Also, it is important for physicians to be aware that it is the medical staff that makes these decisions, in order to avoid pharmacy being perceived as the policeman who is waiting to jump on the unsuspecting physician.¹²⁵ Increasingly, physicians will enter prescription orders into the computer, which can quickly inform the physician of formulary drug choices and guide therapeutic decisions. Currently, however, pharmacists often have to tactfully contact the physician about nonformulary drugs in order to make a formulary system work.

Similarly, pharmacies filling prescriptions for an HMO must be kept informed of the formulary status of drugs. One suggestion is to have a help desk to answer pharmacist questions and to provide information.¹²⁶

Oftentimes, the drug formularies will have a number of other sections that may include information about the P&T committee and pharmacy department, policy and procedure information (e.g., how to obtain nonformulary drugs, how to request a drug be placed on the formulary), laboratory test information, dietary supplement charts, pharmacokinetics information, approved abbreviations, sodium content, nomograms, dosage equivalency charts, apothecary/metric equivalents, drug–food interactions, skin test directions, cost data, antimicrobial therapy charts, and any other brief clinical information tables felt to be necessary. Use of linking in Web sites can make such information much more readily available and usable, since users can navigate back and forth between these tables and the drug list. MCOs may need to include the procedure they use to limit choice of drugs by physicians, pharmacists, and patients.^16,127

In institutional pharmacies, a hardcopy book was normally published once a year in the past. Often it was published in a pocket-size format that could be carried in lab coats by physicians, pharmacists, and nurses. There may also have been a larger loose-leaf binder published that could be updated regularly throughout the year. Such a book is no longer justified.¹²⁸ It is now common for this reference to be available electronically. The electronic form can be made more widely available and can be kept continually up to date by making changes, as necessary, at one central location. Also, the electronic formulary coupled with physician order entry may lead to the most efficient and effective way to encourage or enforce the use of formulary items,^129-131 although there is some evidence that electronic messages may be ignored by physicians.¹³² Also, other information can be included to improve drug therapy. For example, this may include a requirement for a consultation by a specialist or pharmacokinetic monitoring. For outpatient drug formularies this may include quantity level limits and requirements for prior authorizations.

Preferably, the pharmacy can use the information on their computer system to create a formulary that is constantly up-to-date. The information can be accessed as part of the prescription order software and/or it may be interfaced with Web software.¹³³ The latter makes it possible to embed other information easily, but may take further work by the pharmacist. In any case, this information should be available to the physician and other health care professionals wherever necessary—even by wireless connection. As a side note, many institutions do not want information about their formularies readily available to individuals not directly associated with the institution (e.g., pharmaceutical manufacturers, pharmaceutical representatives), but this should not be a problem using Virtual Private Network (VPN) software and firewalls to secure the data—allowing access to only qualified individuals. Increasingly, physicians access this information using iPads or Google Android devices.

PBMs, in conjunction with an organization, may publish a patient pocket formulary or informational Web site in addition to the formulary published for physicians and provided online for pharmacies. These patient pocket formularies or Web sites may contain the top therapeutic categories and other information as well. Within these categories are the key drugs in that specific therapeutic class as well as the designated preferred products and the associated patient cost index. Patients are encouraged to take the pocket formularies on their physician visits as a means of ensuring formulary compliance when discussing therapeutic options. Physicians may also have the capability of prescribing online, whereby the physician enters the prescription in an electronic device and instant messaging occurs alerting the physician to potential drug interactions or formulary status of the prescription, allowing the physician to change the prescription immediately and eliminating the need for a pharmacist to call.^43,134

In addition to pocket formularies, one method whereby the pharmacist educates the physician about formulary drugs is academic detailing. Through mailings, phone conversations, and personal visits the pharmacist discusses with the physician his or her prescribing patterns and, using evidence-based medical literature, supports the rational for preferred formulary product selection and clinically appropriate, cost-effective prescribing without compromising quality.⁴³

It is recommended to use a combination of methods to make sure prescribers are informed about formulary information, including electronic resources, academic detailing, educational programs, and any other available methods.¹³⁵

Evaluating Drugs for Formulary Inclusion

The establishment and maintenance of a drug formulary requires that drugs or drug classes be objectively assessed based on scientific information (e.g., efficacy, adverse effects, cost, contribution to some critical treatment pathway,¹³⁶ ease of preparation/use, and other appropriate items), not anecdotal physician experience.^93,137 Also, it must be noted that the safety of medications is an important consideration and that decisions must not be made purely based on cost.¹³⁸ Also, when costs are considered, it needs to be an evaluation of all costs to the institution, not just the cost of the medication itself, and may include such diverse things as laboratory monitoring costs, length of therapy, nursing care demands, and rehospitalization rates.¹³⁹ Medication selection and procurement were specifically added to the TJC accreditation process under medication management in the 2009 standards.¹⁴⁰ There is an emphasis in the literature that P&T committee activities should be a result of evidence-based decisions.^95,141 Regarding the formulary process, 2013 TJC standard MM.02.01.01 calls for written criteria for addition or deletion of medications.¹⁵ Any health care practitioner who is involved with ordering, dispensing, administering, and monitoring medications needs to be involved with the development of the criteria.^15,140 A process must also be in place to monitor patient responses to a new medication. All formulary medications are to be reviewed at least annually based on safety and efficacy information. This means that in addition to new formulary additions, all categories of the AHFS therapeutic classification should be reviewed at least yearly.

According to the 2013 TJC, the criteria used for approving addition of a drug to a formulary need to minimally include the following:¹⁵

• Indications for use

• Effectiveness

• Risks (e.g., adverse effects, drug interactions, and potential for medication errors)¹⁴²

• Cost

A procedure for preparing the written evaluation of drug products is found in the next chapter; however, this section will go further into how the P&T committee should use that information and other items to do the actual evaluation.

When a P&T committee considers a drug for formulary adoption, it is quite common for the discussion to include statements such as “In my clinical experience…,” which leads the discussion into rather subjective areas. Commonly, physicians are most likely to request drugs after they have met with the pharmaceutical company representative or received compensation from the drug company (e.g., speaking fees and travel funds to a meeting).^132,143 In addition, medications may be requested and added to a formulary simply because they are new, even when they clearly are not superior and cost more.¹⁴⁴ Valid formulary decisions should be based on objective evidence, particularly clinical studies,¹⁴⁵ rather than a few cases of clinical experience by a physician attending a meeting.⁹⁵ Efforts must be made to guide discussions to scientific information when it wanders into vague subjective areas.⁹⁴ In some cases this is rather difficult because many new drugs have limited published information when they are first commercially available. The information that is available is generally placebo-controlled studies that are funded by the manufacturer. In situations such as this, the decision on formulary addition may need to be postponed until adequate information is available. It may be recommended that consideration of any new product be delayed until it has been on the market at least 1 year, unless it is a treatment that is significantly different from those already available.¹⁴⁶ In at least one case it has been bluntly stated that a P&T committee should show leadership by restricting the availability of a drug product if there is no convincing evidence that the product offers meaningful benefits over other available products.¹⁴⁷ Sometimes the decision cannot wait, as is the case with many managed care companies, which need to review a drug before a patient picks up the drug from the pharmacy so that appropriate coverage determination can be made, or in hospitals in response to the new TJC accreditation standards.^15,140

Then the P&T committee’s decision-making process needs to be structured in a manner that is very objective and data driven, and takes into account the lack of data.⁹⁵ In these cases, a committee may make a decision and then place the product on a 6-month follow-up for an additional review, after which time additional prescribing and patient use data or clinical trial data may be available.

While there is a temptation to think that anything new is better, which is an attitude that is certainly pushed by drug company representatives with new products to sell, it cannot be assumed and must be proven. In some cases, experts have determined that the new products pose no significant advantages to the patients to justify the costs.^148-150 Often, manufacturers are trying to get products approved and on the market that may be in a different strength or dosage form, single isomer of a product, a new indication for a product, or even an extended release version of a product (sometimes several different extended-release versions).¹⁵¹ All of the products potentially need to be given consideration by a P&T committee. However, with a lack of published trials and, in many cases, objective and reliable data, the P&T committee faces the challenge of creating a sound drug formulary that represents the needs of an organization or patient population in an objective manner that encompasses current clinical practice, established guidelines of patient care, and a thorough risk-benefit analysis of the drug product.²⁶ Some places have even tried computerized methods to make more objective decisions^152,153; however, there does not seem to be any data demonstrating the superiority of such a method. Similarly, there are processes called System of Objectified Judgment Analysis (SOJA), which uses a computer program to score different aspects of drugs in the same class to determine the best product,^154,155 and multiattribute utility technology.¹⁵⁶ A Web-based tool for designing pediatric vaccine formularies has been developed (http://www.vaccineselection.com).¹⁵⁷

The 2013 Joint Commission Accreditation Process Guide for Hospitals also addresses the elements of performance for selecting and procuring medications.¹⁵ Elements of this performance that provide additional information to that already covered are the following:

1. Members of the medical staff, licensed independent practitioners, pharmacists, and staff involved in the ordering, dispensing, administering, and/or monitoring the effects of medications develop written criteria for determining which medications are available for dispensing or administering to patients.

2. Before using a new medication, the hospital establishes processes to monitor patient response (see MM.07.01.01, EP 2).

Conflict of Interest

Also, it is necessary to determine whether people involved in the discussion and decision about a drug’s formulary status have some conflict of interest (i.e., would receive some direct or indirect compensation from having a drug available, e.g., stock in a company, honoraria for speaking, consulting fees, and gifts or grants from a company^{83,146,158-160}) and avoid that biasing factor. Nationally, this is considered to be a significant problem.¹⁶¹ The P&T committee has the responsibility to identify and address conflict of interest issues in the decision-making process.⁹⁵ Perhaps a conflict of interest policy, requiring regular disclosure of any possible conflicts, needs to be established.^26,162,163 An example form to gather information about conflicts of interest is found in Appendix 12–6. Also, the ProPublica Web site (http://projects.propublica.org/docdollars/) discloses payments to prescribers from some pharmaceutical companies. In certain cases, regular voting P&T committee members may have to abstain from the vote if they disclose a possible conflict of interest or the committee may vote to determine whether the conflict is considered to be significant enough to prevent voting by the individual in question. There is concern at a federal, state, and institutional level regarding potential conflict of interest. In 2009, some drug manufacturers made public their financial relationship with health care providers.¹⁶⁴ There is also concern that the PBMs P&T committees may be financially influenced by drug manufacturers.¹⁶⁵ Unlike the traditional health insurers, the U.S. Department of Defense solicits input from various providers and beneficiaries. In addition, they provide beneficiaries and their representatives with an opportunity to comment on the committee recommendations prior to final approval. However, this has not deterred their placement in a category where they will provide the lowest reimbursement for the product.¹⁶⁶

Other Aspects of Formulary Evaluation

Several other areas need to be considered, which will be explained below.

Patent expiration is a common question that should be considered for all products or drug classes undergoing formulary review, since the introduction of generic products after that date may lead to decreasing prices. Patent expiration information can be found at http://www.fda.gov/cder/ob/default.htm.

TJC Medication Management Standards for 2013 are focused on medication safety. The definition of a medication goes beyond prescription products and the FDA classification as drugs. Also considered medications are herbal/alternative therapies, vitamins, nutraceuticals, nonprescription products, vaccines, diagnostic and contrast agents, radioactive agents, respiratory treatments, parenteral nutrition, blood derivatives, intravenous (IV) solutions, anesthetic gases, sample medications, and anything else deemed by the FDA to be a drug.¹⁴⁰ The pharmacist is required to review the appropriateness of all medication orders before a medication is dispensed.^15,140,167

While it is desirable to evaluate herbal or other alternative medicine products,^168-170 some institutions may instead handle them as nonformulary requests or investigational drugs.¹⁷¹ Although alternative and herbal medications seem somewhat unusual to the P&T committee, they can still be treated much the same way as any drug product, perhaps with additional evaluation of the purity and composition of the products (see the Dietary Supplement Medical Literature section of Chapter 5 for additional details regarding how to evaluate for these products).¹⁷² Some pharmacies also have other policies and procedures,¹⁷³ perhaps some that are highly restrictive,¹⁷⁴ including requiring pharmacists to verify labeled product ingredients.¹⁷⁵

The possibility of a new drug product leading to medication errors should also be considered in the evaluation of products. Such things as difficulty in dosing or administration (including programming intravenous infusion pumps), black box warnings, look-alike and sound-alike names, the need for extra monitoring, unusual storage requirements, and other issues may be considered.¹⁷⁶

In addition to considering the cost of drug products in the institution, it is necessary to consider the cost to the patient, once he or she returns home. If a product is so expensive that an uninsured or underinsured patient cannot afford it in the ambulatory environment, it may not be good to place the patient on that drug in the hospital. However, in some cases pharmaceutical companies may offer assistance to this type of patient.

Open versus Closed Formularies

When setting up a drug formulary there are several things to consider. First, whether it will be an open or closed formulary.¹⁷⁷ The open (or voluntary) formulary essentially means any drug on the market is available, and some would argue that the term open formulary is really an oxymoron.⁹⁴ One exception to this definition is that the NCQA states that an open formulary for an MCO can be a list of recommended drugs, as long as there are no requirements concerning its use.¹⁷⁸ A closed (or restricted) formulary means that only a limited number of agents are available.⁹⁰ This is certainly preferable, because such agents should be chosen by objective evidence in the scientific literature. The evidence should support the superiority of the agents over other similar drugs and because closed formularies can result in cost savings.¹⁷⁹ Closed formularies are becoming much more common in HMOs.^180,181 In some instances of closed formularies, patients may have access to these nonformulary or nonpreferred drug products by paying a substantially higher copayment, the difference between the formulary and nonformulary products in addition to the copayment, or the nonformulary drug in its entirety unless there is a prior authorization to allow this drug.⁴²

Issues may arise with a closed or restricted formulary in that it may be too restrictive for those patients who cannot afford the drug, even though the drug is still available on a closed formulary. A growing health policy concern is the ability to successfully appeal for coverage of a nonformulary product. Newer breakthrough medications and biotechnology products are making their way onto the market. Although clinically valuable, they are very expensive. In addition, PBMs have managed or preferred formularies. In a managed or preferred formulary, interventions may be used to encourage physicians to use the preferred products. Some of these interventions for physicians include academic detailing, prior authorizations, and coverage rules. For pharmacies this may mean a higher dispensing fee for formulary compliance. For the patient this may mean higher copayments if the formulary or preferred product is not used.

Unlike hospitals, PBMs along with their clients (i.e., health plans) place their formulary and nonformulary medications into tiers with an associated copayment with each tier. This tier copayment structure came about in response to the rising cost of prescription drugs. The first tier is generally reserved for generic drug products. This tier usually has the lowest copayment (e.g., $10.00). The second tier is usually reserved for those name brand drugs that are formulary (e.g., $15.00). This tier has a higher copayment than the first tier due to the added cost of the brand name drug. The third tier is reserved for those drug products that are nonformulary brand names. This copayment is significantly higher than the other two tiers (e.g., $30). However, some third tier copayments may be calculated as a proportion of the drug cost, even as much as one-third as a form of coinsurance, or require paying for the drug in its entirety. The reason for the copayment structure is to encourage the patient to use the most clinically appropriate, cost-effective drug without compromising quality care.⁴² Decisions as to the tier placement of a drug product may be dependent on comparative effectiveness research.¹⁸²

The closed formulary can also be broken down into what is referred to as positive or negative formularies. This is the method by which the formulary is developed. A positive formulary effectively starts with a blank sheet of paper and specifically adds agents. While this is probably the best method to limit the number of drugs available, it is often not very popular when first implementing the formulary because every agent must be considered. That means the physicians must even make specific decisions on whether they should add such things as acetaminophen and amoxicillin to the formulary. Therefore, in hospitals just establishing a formulary, it is often more popular and easier to use a negative formulary system. This essentially starts with the current hospital drug stock, with each drug class being evaluated to eliminate agents that are not necessary.¹⁸³ The first steps in this process may be as simple as eliminating multiple salts/esters of the same drug. Then classes of drugs with multiple similar products could be addressed (e.g., analgesics, antacids, laxatives, vitamins, and topical steroids). While in some ways this process is easier, it is also likely to result in a much bigger formulary, since the decision will be made as to what drugs are definitely not needed, rather than which drugs the institution definitely needs. However, the specific institution’s situation will need to be assessed before the method of determining the formulary items can be decided on. Overall, the goal is to provide an optimal array of agents. It is easy to end up with too many duplicative agents; however, having a greater number of agents to choose from can lead to better patient care in some areas.^184,185

Therapeutic Interchange

The AMA^12,177 defines therapeutic interchange as “authorized exchange of therapeutic alternatives in accordance with previously established and approved written guidelines or protocols within a formulary system.” An example would be the use of cefazolin in specific doses whenever any other first-generation injectable cephalosporin is ordered. Please note that this concept is different than biosimilar substitution in which the FDA has determined that specific biologic products (i.e., not drugs in general) are similar except for minor differences in clinically inactive components, with no meaningful differences between the biologics in safety, purity, and potency.¹⁸⁶ Biosimilar substitution may allow something very similar to therapeutic interchange, even in community pharmacies, depending on state laws that are being updated to allow for it; however, it does not require action of a P&T committee. Therapeutic interchange is used in nearly 90% of U.S. hospitals¹⁸⁷ for reasons that include cost savings,^188,189 improved patient outcomes, decreased adverse effects, decreased inventory, fewer medication errors,¹⁹⁰ or other benefits. Therapeutic interchange has been shown to decrease costs without adversely affecting patient outcomes.^52,191 There is even reason to believe that when therapeutic interchange is properly performed, and not entirely based on financial considerations, it may produce lower legal liability on an institution,⁸⁴ although there are no published legal cases regarding therapeutic interchange to demonstrate either increased or decreased legal liability.¹⁹² The concept of therapeutic interchange through collaborative interactions with interdisciplinary teams to develop protocols and comprehensive therapeutic assessments has been described. Several medication classes may be the target of therapeutic interchange and an aggressive intravenous to oral conversion may be part of this process.¹⁹³ The most common classes of drugs for therapeutic interchange are, in order: H₂ antagonists, proton pump inhibitors, antacids, quinolones, potassium supplements, cephalosporins, and hydroxymethylglutaryl-coenzyme A reductase inhibitors.¹⁹⁴ Some drugs classes, such as low-molecular weight heparins, that at first glance may appear to be possible places for therapeutic interchange, may be found to be unacceptable after a closer inspection.¹⁹⁴

Therapeutic interchange is considered acceptable to the AMA, unlike therapeutic substitution, which they define as the “act of dispensing a therapeutic alternative for the drug product prescribed without prior authorization of the prescriber” (Note: prior authorization may be a blanket authorization, not a specific authorization for each case).^195,196 Therapeutic interchange has also been found to be acceptable by other organizations, including the American College of Clinical Pharmacy (ACCP), American College of Physicians (ACP) (they require immediate prior consent by the physician),¹⁹⁷ ASHP, American Pharmacists Association (APhA), American Association of Colleges of Pharmacy (AACP), AMCP,¹⁹⁸ and the American Society of Consultant Pharmacists (ASCP).^199,200 The ACCP spells out the concept of therapeutic interchange in great detail and suggests that it not only be conducted under the auspices of a P&T-type committee, but also that it specifically include DUE, a set method for informing the physicians and other staff that interchange is taking place (should be well planned and thorough²⁰¹), and a mechanism under which the therapeutic interchange policies may be overridden in specific cases. Evaluations for therapeutic interchange should also consider medical, legal, and financial evaluations.¹⁹⁴ Other practical aspects, such as communication forms, policies and procedures, medical staff bylaw changes, and other items may need to be addressed by the institution.²⁰² Electronic means to provide authorization for a therapeutic interchange may be a future option.²⁰³ Outside of an institution (e.g., ambulatory environment), therapeutic interchange may not be as easy to implement due to practical procedure methods and because patients are not as closely monitored; however, it may still be possible.^204,205 In the ambulatory situation, the AMA states that therapeutic interchange recommendations must be approved by the majority of physicians affected and must otherwise follow similar standards to that described for inpatient settings.¹⁷⁷

The consideration of certain therapeutic agents for interchange may result in strong differences of opinion among medical staff members regarding their appropriate use. The process for evaluating any product, especially those having deeply held physician opinions, should be followed, along with efforts being made by committee members to actively approach appropriate influential individuals before a crisis occurs. Through anticipatory, structured negotiation, it is more likely that rational and balanced decisions will be made. Also, it is necessary to take into consideration whether a short-term interchange of products, while the patient is in a hospital, may cause confusion or other difficulties when the patient returns to the outpatient environment and may be restarted on the original agent.²⁰⁶ Working with the physicians to resolve this issue is a necessity for the long-term care of patients.

Generic substitution can also be considered by the P&T committee, but many pharmacies consider generic substitution to be one of their responsibilities and do not take such decisions to a P&T committee for approval. The one exception may be drugs with narrow therapeutic indexes (e.g., anticonvulsants), where a P&T committee may determine a list of products where generic substitution is not allowed,²⁰⁷ although the FDA insists that such precautions are unnecessary.²⁰⁸ In relation to generic substitution, it must be mentioned that pharmacies must determine quality suppliers. The ASHP has guidelines for this function.²⁰⁹ Also, states may have a variety of laws governing generic substitution. They may also publish so-called positive and negative formularies, which differ in definition from those terms used elsewhere in this chapter in that they are lists of drugs that may or may not be substituted for one another, respectively.¹⁹²

In some instances, physicians may prefer that no generic substitution or therapeutic substitution occur on a written order or prescription by indicating “Dispense as Written” (DAW) on that document. This can occur in the inpatient setting as well as the outpatient setting. Depending on the state, dispense as written is synonymous with the following: no substitution, do not substitute, medically necessary, brand necessary/medically necessary, no drug product selection, brand medically necessary, substitution prohibited without permission of physician or patient, or no substitution/brand necessary.

In most states, the law provides that pharmacists can use a generic version of any medication on a prescription or medication order if the physician has not precluded that action by indicating DAW. In the outpatient setting, in general, if a patient wants a generic medication, they should be sure that their pharmacist knows of their desire.

In some benefit plans, if the physician requests a brand name medication when a generic equivalent is available, the patient member may be responsible to pay the difference in cost in addition to the generic copayment. In some instances, members may not be required to pay this cost difference, if their physician documents that the brand name medication is necessary.

Nonformulary Usage

Many institutions track the drug use patterns of prescribers, as was mentioned previously in describing the tracking of nonformulary drug products.²¹⁰ Annually, a listing of nonformulary products and expenses should be made available to the P&T committee. It is helpful if the pharmacy director can report the total cost of nonformulary items as a percent of the total budget, particularly since the cost can exceed the cost of carrying the nonformulary product on the formulary.²¹¹ Also, as part of this, it is good to check on whether nonformulary drug usage has led to medication errors, since there was at least one report that such nonformulary use resulted in a 28% error rate.²¹⁰ Ideally, a report of the number involved and costs of nonformulary orders will be made available to each prescriber. This process is helpful in improving the appropriate use of medications and has also been linked to the prescriber credentialing process.²¹² The process can also be used to reevaluate whether nonformulary items should be made available on the drug formulary.

Unlabeled Uses

While some third-party payers may attempt to limit the use of drugs to only FDA-approved indications, this may unnecessarily restrict use of products for indications that may have significant literature support. This should not be supported.²¹³ However, as will be discussed in more detail in the next chapter, it is sometimes necessary for institutions to specifically restrict drugs to specific uses when they may be used inappropriately. While at first glance, this seems to be the same, in reality, such restrictions may be totally unrelated to approved labeling. In this situation, it may be found that products are permitted to be used for unlabeled indications where there is adequate literature support and, conversely, may not be permitted to be used, at least without special approval within the institution, for FDA indications when there may be more appropriate drugs available.

New Product Introductions

When new drug products are added to the formulary, it is best to prepare physicians, nurses, and others.¹³² Initially, it is necessary to inform affected individuals that the drug will be available as of a specific date. That could be immediately or at some time in the near future. There are various reasons for a delay. For example, a drug may have been approved by both the FDA and the P&T committee, but the company may not have yet made it commercially available because they have not yet produced a sufficient supply or they are not yet ready to start their marketing efforts. In some cases, it is necessary for specific equipment to be obtained and installed. Such was the case a number of years ago when Fluosol^®-DA was made available for a limited period of time. This parenteral product required very specialized preparation method involving a warm water bath and percolating a mixture of gases through an IV bag under sterile conditions. Few, if any, pharmacies had the necessary equipment at the time of introduction and it would have taken some time to get the equipment, set it up, and train pharmacists and technicians in its use, requiring a delay in making the product available in an institution. Most commonly, the reason for the delay is likely to be the time it takes to inform all individuals likely to be involved in the prescribing, preparing, and administering of the drug that the drug will be available and to educate them in the proper use, including applicable policies and procedures. These education efforts may be provided through newsletters, Web sites, portals, e-mail, memos, educational programs, RSS (Really Simple Syndication) aggregators (programs that pull together information from a variety of sources, such as news resources—an example is Google Reader), or other methods. The method chosen should generally be a standard method used within the institution and should be appropriate for the specific medication product introduction. In cases where a product is particularly complicated, dangerous, or prone to misuse, several methods of instruction, perhaps along with prescribing restrictions, should probably be employed. Further information about newsletters and Web sites is found in Chapter 9.

POLICIES AND PROCEDURES

Occasionally, policies and procedures must be developed to support the rational use of medications. While the pharmacy department may decide they need to have their own policies and procedures for internal functions that is not the focus of this discussion.²¹⁴ Instead, policies and procedures for the use of medications in an institution, clinic, and so forth will be discussed, since that is often provided through a P&T committee.

TJC has specifically stated that they expect policies and procedures for the following types of orders¹⁵:

• As needed (prn) medications

• Standard order sets

• Automatic stop

• Titrating

• Taper

• Range

• Compounded or admixed drugs

• Medication-related devices

• Investigational medications

• Herbal/natural products

• Discharge medications

• Anticoagulation dosing⁵⁵

Some examples of policies and procedures can be found on the Internet at http://www.hosp.uky.edu/pharmacy/departpolicy/departmentalpolicies.html

To begin this discussion, the definitions for policies and procedures should be considered.²¹⁵ A policy is a broad general statement that describes the goals and purposes of the document. The procedures are specific actions to be taken. In some ways, policies and procedures may resemble a cookbook-type approach, in that a set of steps to be accomplished are described in order. Taken together, these policies and procedures may be a logical, step-by-step explanation of why and where a product may be used, how to use it, and who is to follow the policy (i.e., there may be different portions of the document addressed to pharmacists, technicians, nurses, and prescribers),²¹⁶ along with a brief introductory statement describing why the process is necessary.

Before developing a specific policy and procedure, the first step should be deciding whether it is necessary at all. In other words, is there a good reason for the existence of that particular policy and procedure and is it likely to be used? This can be looked at as a risk-benefit decision. For example, is there sufficient risk that a particular medication will be used incorrectly (e.g., prepared wrong, administered wrong, and used for an inappropriate indication) to make it worthwhile to develop a policy and procedure? Generally, the answer will be no, but in a certain number of cases, policies and procedures may be necessary. Examples of where a policy and procedure may be necessary include thrombolytic agents (where the drug can cause serious or fatal effects if used improperly), antibiotics (where it is found that expensive, broad-spectrum antibiotics are being used where amoxicillin should suffice), injectable drugs (where specific individuals who will administer the medication and the process, including programming infusion devices, will be defined),²¹⁷ and even for drugs where reimbursement may be a problem.

Once a decision is reached to develop the policy and procedure, a logical and orderly course should be followed. It is undesirable to wait until after problems occur before deciding that policies and procedures are necessary. This process should follow the drug formulary process, where a mechanism is set up to help determine that a policy and procedure is necessary. In many cases, a policy and procedure for use of drugs likely to be misused may be developed in conjunction with its consideration for addition to the drug formulary.

As in any process, it is first necessary to decide who will be coordinating the effort and the likely endpoint. That person, or designee, will then need to investigate various sources for background material necessary to develop the policy and procedure. This might include doing a literature search, talking to experts in the field, talking to other institutions that have already developed policies on the same topic, reviewing published professional (e.g., http://www.ashp.org/Import/PRACTICEANDPOLICY/PolicyPositionsGuidelinesBestPractices.aspx) or clinical guidelines (e.g., http://www.guideline.gov), and checking the institution’s requirements for developing policies and procedures. If the policy and procedure is for a hospital group, other institutions in the group must also be involved. In particular, it is necessary for the person developing the policy and procedure to have good communications with those who will be affected. After all, if the final product is looked at as being more trouble than it is worth, it is not likely to be followed. Where the policy and procedure fits in relation to other institutional policies and procedures will also have to be evaluated. Finally, a document should be written, reviewed, and revised, using many of the skills outlined in Chapter 9.

As part of the process of preparing the policy, it is important to be clear as to when it is applicable and where there may be exceptions. For example, institutions have policies for the automatic stop of specific medications (e.g., stopping an antibiotic after 7 days). There needs to be careful consideration of only applying that policy in cases where it will be likely to improve drug therapy. There also needs to be a mechanism to make sure that such an automatic stop, which may be programmed into the computer system, may not cause harm to particular patients²¹⁸ (e.g., patients with osteomyelitis receiving antibiotics for an extended period of time).

Once the policy and procedure is finished, it will need to be approved by the same mechanism that drug formulary changes go through (i.e., P&T committee, medical executive committee, and so forth). The approval and/or effective date for the policy and procedure should be recorded on the document itself to ensure it is not confused with earlier or later documents. A plan for implementing the policy and procedure will need to be developed. Forms may need to be prepared and distributed. Copies of the policy and procedure will have to be distributed to those affected (preferably on the computer network), and educational programs will need to be planned and given. At that point, the policy and procedure can be implemented, perhaps in conjunction with the first appearance of a particular agent on the drug formulary. That is not the end of the process, however. At some point, the policy and procedure should be evaluated to determine if it is being properly followed and having the desired effect as a part of a quality assurance plan. A method to enforce compliance with the policies and procedures is required and it is necessary for legal reasons to demonstrate that this enforcement method is used.²¹⁶ Also, the policy and procedure will need to be reviewed, revised (if necessary), and reapproved on a regular basis (preferably once a year). As part of that process, the actual need for the policy and procedure should be reconsidered. The policy and procedure should be eliminated if no longer needed. One way to determine whether the policy and procedures are consulted is if they are on a Web server, where the number of times the specific page is opened is recorded. Superseded copies (i.e., previous versions) of the policies and procedures should be kept on file for background and legal purposes.

It is also necessary to have policies and procedures for the operation of the P&T committee itself (see Appendix 12–1 for policies and procedures for setting up a P&T committee). Some examples of other policies and procedures that may need to be developed include how new drugs are requested for addition to the formulary, how nonformulary drugs can be used, what procedure is used to evaluate new drugs,¹⁴⁰ the composition of the committee, and other committee functions (e.g., conflict of interest). These have been discussed elsewhere in the chapter and will not be dealt with further at this point. For more information on writing policies and procedures, refer to Chapter 18.

P&T committees may be involved with the development, alteration (to fit local circumstances), and/or approval of evidence-based clinical guidelines. The reader is directed to Chapter 7 to obtain further information.

Many prescribers, both in their offices and in institutions (e.g., hospital and nursing home), make use of something called standard orders. This usually consists of some sort of form, preprinted hardcopy, or electronic checklist, which lists various orders that are often written for specific patients under certain circumstances. This can include medications, laboratory tests, x-rays, other diagnostic tests, diet restrictions, preoperative preparation, restrictions, and many other things. For example, there may be a specific set of orders for all patients a prescriber admits to the hospital in general or for a specific diagnosis, or a set of orders for a patient who is scheduled to undergo a specific procedure, such as an operation. Standard order sets are commonly used for some medications, such as total parenteral nutrition solutions and oncology agents, where the order can be complex and confusing, perhaps resulting in potential medication errors. The prescribers using the standard order sets can simply indicate which of the items they wish their patients to receive and provide various necessary details, such as dose or duration. The use of standard order sets can be a very good practice, since they act like checklists used by pilots or astronauts—saving time and ensuring that important items are not inadvertently missed or misused. This can be particularly important in the use of drugs that can be dangerous or ineffective if not properly used, such as chemotherapeutic regimens in oncology patients. However, the disadvantage is that the standard order sets do take time to establish and maintain, and may not keep up with actual practice standards, therefore, contributing to the perpetuation of outdated or inappropriate practices. While many P&T committees do not address standard order sets directly, leaving them to the individuals or groups that use them, it is something that still needs to be considered for several reasons.

First, P&T committees are responsible for overseeing all things related to medication use in an institution. Second, the standard order sets may contain medications that may be removed from the formulary for various reasons. This requires the P&T committee to make a special effort to communicate with those individuals or groups with standard order sets that contain drugs that may be eliminated from the formulary. This communication should begin prior to recommendation for removal of a product from the formulary, in order to find out the reason for the use of the product and the acceptability of available substitutes. By maintaining copies of standard order sets, the pharmacy department can help facilitate this process. Also, once it has been decided that a particular product on standard order sets is to be removed from the formulary, that decision must be quickly communicated to the affected individuals and groups, with enough time allocated before the removal becoming effective for the standard order sets to be updated and the new ones be put into use. This process may be delayed by the frequency of meetings of the groups affected, the time it takes to have new standard order set sheets either printed or put on the computer system, and the necessity to adequately train personnel in the use of the replacement products. In all likelihood, it may take several months after a decision by the P&T committee before the changes can be put into effect. Finally, P&T committees may find that products on standard order sets may be used in ways that are not supported by the medical literature and/or hospital policy, which means that they need to make sure the prescribers or groups that use those orders make necessary changes.

Optimally, individuals or groups using standard orders should be required to review and reapprove their use on a regular basis (probably at least once a year). It may also be necessary to have standard order sets go through an institutional standard order sets committee. In any case, TJC requires a specific policy and procedure for how institutions handle standard order sets.¹⁴⁰ Any changes should be reported to both the affected groups (e.g., nursing units, pharmacy, and information technology) and the P&T committee in cases where the standard order sets include drugs. All printed sets of the standard order sets must include their revision date, to make sure that that old copies are not inadvertently used. Old copies of the orders must be maintained for medicolegal purposes, with the length of time for keeping such records to be determined by the institution’s legal counsel.

Health care institutions are required by various groups to verify that physicians and other health care professionals have the credentials to practice.²¹⁹ This can include degrees, licenses, training, and experience. Based on the credentials, professionals may be given privileges to practice within that institution and perform certain activities.²²⁰ Please note that this term is privilege, not right. For example, while all physicians may have the same license, only those trained in surgery may be allowed to do more than very minor surgical procedures (e.g., suturing lacerations and removing minor skin growths). There may be even more specific rules, such as those preventing a chest surgeon from performing neurosurgery. These privileges can also extend to drugs. For example, it may be decided within the P&T committee that only oncologists have privileges to prescribe most antineoplastic agents. This type of policy and procedure is the basis for some restrictions that may be placed when a drug is considered for formulary addition. In addition to restrictions placed within an institution, restrictions may be enforced from outside the institution. For example, the use of dofetilide (Tikosyn^®) requires the credentialing of both the prescriber and the hospital by the company; see http://www.tikosyn.com/ for details.

It also must be mentioned that policies and procedures may be in place within an institution to require pharmacists to perform certain operations, whether that is the preparation of particular agents or performing specific clinical functions (e.g., pharmacokinetics and warfarin dosing).²¹⁹ Institutions may have a method by which pharmacists are credentialed to perform such services. Further credentialing of pharmacists may be necessary in the future if pharmacist interdependent prescribing becomes more common.²²¹

❺ A variety of topics regarding the quality of medication use, inclusive of applicable medication metrics, are normally part of the activities of a P&T committee, especially timely communication issues. Many of these activities are covered in Chapter 14; however, the items described in the following sections may be considered to be specific to the P&T committee.

MEDICATION QUALITY ASSURANCE

In addition to determining which medications are available and providing direction in their use, it is required that the quality of use is regularly measured in whatever areas are felt to be necessary, including medication use evaluation (MUE), drug use evaluation (DUE), and other similar activities. The P&T committee will likely be involved in this, although coordination of such efforts, including preparing an annual plan of quality assurance activities, may be through other groups, such as a quality assurance committee. The initial plan may be developed by pharmacists, but multidisciplinary feedback is essential before the focused areas of evaluation are finalized. Ideally, all practice areas of the medical staff are given opportunity for input into these focused evaluations. The project list should be continually reviewed and allow for special urgent projects when necessary. If a project is not completed during the year, it may be reconsidered for the next year. DUE criteria should be selected that can be used for continuous improvements that meet TJC accreditation requirements. DUE activities may be used to identify ADRs, contain cost, and expand clinical pharmacy activities.²²² Even if the P&T committee does not direct quality assurance efforts, they must be kept informed of the information gathered and the medication-related quality improvement efforts that are being instituted. This way the P&T committee can be supportive of such efforts directly (e.g., making changes to the drug formulary or policies and procedures to improve medication use) or less directly (e.g., providing statements supporting such activities). Quality assurance is a large topic and further information is available in Chapter 14.

ADVERSE DRUG REACTIONS

The P&T committee has a responsibility to review adverse reaction data in an institution to identify trends. One tool they can employ is to monitor the use of medications, sometimes referred to as tracer drugs, to treat the symptoms and side effects of other medications,²²³ for example, the monitoring of epinephrine, flumazenil, phytonadione, or protamine to try to detect allergic responses, benzodiazepine overdoses, warfarin overdoses, or heparin overdoses, respectively. The topic of ADRs is covered more in Chapter 15.

MEDICATION ERROR INCIDENTS

Data collected regarding medication errors may be reported to the P&T committee and, probably, for investigational drugs, to the IRB. A systematic method to collect data about medication errors must be set up within an institution, perhaps using internal incident report forms employed by the institution to track all unusual occurrences regarding patients. All incidents are reviewed by severity (none, minimal, moderate, major, death) and process (prescribing, transcription, dispensing, administration, other). A multidisciplinary review of all incidents should take place and trends in the specific quality indicators should be shared with the entire professional staff. High-alert medications (e.g., narcotics, patient-controlled analgesia, insulin, anticoagulants, electrolytes, neuromuscular blockers, thrombolytics, and chemotherapy) should be benchmarked and followed to identify trends to improve the medication management system and ultimately enhance patient safety.

Another monitoring consideration is related to errors with medical devices and may also be monitored by these committees. A study completed in a 520-bed tertiary teaching institution demonstrated that more intensive surveillance methods yielded higher rates of medical device problems as compared to voluntary reporting.²²⁴

The topic of medication errors is covered in more detail in Chapter 16.

ILLEGIBLE HANDWRITING, TRANSCRIPTION, AND ABBREVIATIONS

It is important to work with the medical staff and all other health professionals regarding illegible handwriting and transcription errors. Typically, a task force assigned by the P&T committee is given the charge of evaluating and trending illegible handwriting, followed by developing process improvement measures. A report can be made to the P&T on an ongoing or quarterly basis. An education process must be in place for those individuals who consistently demonstrate poor handwriting. Hands-on reminders have been helpful or, in some extreme cases, handwriting school is recommended. In addition, institutions have adapted TJC unapproved abbreviation list.¹⁵ Unacceptable abbreviations may have an intended meaning but often are potentially misinterpreted and can lead to serious complications. In many institutions, the nurse or pharmacist must clarify the order with the prescriber when an unapproved abbreviation is written. In some cases, the only effective prevention of this problem has been when the medical staff has determined through the P&T committee that orders containing unapproved abbreviations are invalid and must be rewritten by the physician.²²⁵ The addition to the formulary of look-alike, sound-alike medications is discouraged.^226-229 Increasingly, institutions are implementing computerized physician order entry (CPOE), which eliminates the problem of illegible handwriting and decimal point errors, thus reducing medication errors,²³⁰ although implementation costs are considerable and some institutions may currently feel that it is not yet worth the effort and expense.²³¹

TIMELINESS

The time for medication orders to be filled and sent to the floor may be tracked by the P&T committee. One area of importance is the response time sequence for a stat (immediate) order. The time should be evaluated from the time the order was written, to when the order was filled, to when the patient receives the medication. There are many obstacles in the order process and getting the medication to the patient. Each institution should have a standard expectation of the turnaround time for stat orders and a policy that will ensure that the medication is dispensed and administered promptly. Benchmarking should be done to make sure the policy is followed.

Although not quite as imperative, the timeliness of ordinary order fulfillment must also be evaluated for appropriateness.

COUNTERFEIT DRUG PRODUCTS

Counterfeit drugs can be considered to be those that do not contain the ingredients claimed on the labeling, perhaps having no active ingredients, incorrect dose, or even other drugs.²³² Counterfeit drugs appear to be an increasing problem, although the actual incidence is unknown.²³³ The ASHP announced in February 2004 that it would partner with the FDA in a program to keep pharmacists informed about entrance of counterfeit drug products into the nation’s drug supply. The ASHP planned to provide rapid alerts to hospital pharmacy departments about counterfeit drug incidents.²³⁴ Also, there are methods being developed or implemented that will help ensure the pedigree of products, particularly those imported from foreign countries, to help avoid counterfeit products. This may include the use of radio frequency identification (RFID) tags to help track products.²³⁵

The FDA Web site may be consulted at http://www.fda.gov/Safety/MedWatch/ SafetyInformation/SafetyAlertsforHumanMedicalProducts/default.htm for an updated list of counterfeit products. Because of the potential problems associated with counterfeit drug products, the P&T committee must be kept informed of any situations that affect the institution, as should the medical staff as a whole.²³³ This topic also may be handled with medication errors, since it leads to such errors.

SAFETY ALERT

A variety of other safety-related items are also important to P&T committees, including recalls, black box warnings, risk evaluation and mitigation strategies (REMS) (see Chapter 22),¹³⁸ and product shortages, which will be covered in the following subsections. The items covered in this section can also be considered related to ADRs and medication errors, since some portions fit under those categories.

Recalls

The 2013 Joint Commission Accreditation Process Guide for Hospitals requires that a policy and procedure be in place, and be implemented when necessary, to retrieve recalled or discontinued medications. This policy must involve notification of prescribers and patients.¹⁵ The pharmacy department constantly reviews medication products recalled by the manufacturer or the FDA due to a safety issue.²³⁶ This information is provided to the pharmacy by the wholesaler and manufacturer. If a product lot number involved in the recall is found in the pharmacy inventory, that product should be removed from the inventory immediately and recalled from other areas of the institution that may stock it.¹⁴⁰ In the outpatient environment, a recall from consumers may be necessary. A report of medications that have been pulled from the pharmacy inventory should be made available to the P&T committee and the committee may need to decide whether or not to identify patients who may have been affected by the safety issue. Further actions would be based on these findings. The P&T committee chair should be contacted when a patient has significant consequences in relation to a product recall. When a product recall requires the removal of a product treating a disease with limited alternative treatments from the pharmacy inventory, therapeutic alternatives must be made known to the prescribers.¹⁰

The safety of medications is under constant evaluation and the safety of new agents cannot be known until the product has been on the market for a period of time.²³⁷ Some newly reported serious adverse effects result in black box warnings being inserted in the product labeling or REMS, due to requirements of the FDA, which may necessitate action up to the withdrawal of the medication from the market, as was done with propoxyphene.²³⁸ The reason for this name is that the warning is set off from the rest of the information in the package insert by a thick black box that is drawn around it. It is the responsibility of the P&T committee to review safety data for every medication on the formulary. Many P&T committees have a standing agenda item to review all new black box warnings or newly released FDA safety alerts for medications (obtainable from http://www.fda.gov/Safety/MedWatch/default.htm). The P&T committee needs to review the safety data and make any formulary, policy and procedure, and/or other changes as required. The black box safety data of formulary products need to be disseminated to the medical staff, including any special restrictions or actions taken on a specific product. 2013 TJC Standard MM.02.01.01 addresses the hospital’s role in selecting and procuring medications and their annual review for safety and efficacy.¹⁵

Product Shortages

Product shortages should be continuously monitored by the pharmacy department in an organized fashion; this is a TJC requirement.^83,140,236 Information on this can be found at http://www.fda.gov/Drugs/DrugSafety/DrugShortages/default.htm or http://www.ashp.org/shortages. It is possible to get a free e-mail of these shortages or subscribe to an RSS feed. In recent years, there has been a trend toward more frequent medication shortages.²³⁹ In some cases, evaluation of information may show that acceptable alternative products or treatments may be interchanged for products affected by a shortage. The appropriate health care professionals (e.g., physicians, drug information service, pharmacy director, and buyer) need to be immediately notified of product shortages that may have an effect on therapeutic outcomes, along with plans or recommendations on how to address the situation.²⁴⁰ In some instances, the chief of the medical staff and even the ethics committee may be consulted when policies need to be put into place to ration drug supplies. The shortage of intravenous immunoglobulin (IVIG) in the 1990s necessitated a complete medical staff and pharmacy department agreement for appropriate patient selection for treatment.²⁴¹ This shortage required product rationing with the available supply. Unfortunately no therapeutic alternatives were available for the IVIG shortage. Methods of alerting medical staff of shortages include personal communication, the use of posters or message boards in key areas of the hospital (e.g., medical staff lounge, dictation area, parking garage, and high traffic areas), e-mail, smartphone notification, computer/tablet notification during physician order entry, and the use of newsletters or faxes. A guideline is available from the ASHP to aid in determining how to handle a variety of types of shortages.²³⁶

In today’s health care environment, it is essential to keep medication shortages as a standard agenda item for each P&T meeting. Products with limited availability and products that are not available need to be evaluated constantly. Formulary alternatives for these product shortages then need to be communicated to the medical staff.

INVESTIGATIONAL REVIEW BOARD ACTIONS

While P&T committees are generally responsible for overseeing all aspects of medication use in a hospital, they often turn the major responsibility for overseeing investigational drug use over to an IRB. The IRB should provide a regular overview of its actions to the P&T committee for review, but oftentimes this is all that is done. Further information about IRBs can be found in Chapter 17.

COST, BUDGET, AND FORECASTING

How does the P&T committee actively balance its quality promoting activities as well as the economic requirements of its parent organization? For an individual hospital, this is probably an easier task as long as the economic pressures on the hospital’s margin are manageable. As previously mentioned, a closed formulary can result in lowered costs within an institution.¹⁷⁹ However, the P&T committee decisions will be more difficult for the PBM function of a health insurance company or HMO. In the latter situation, the pressures of cost containment, the contents of an insurance plan’s Certificate of Benefits, and the applicable payer regulations represent formidable obstacles for building broad support for the decisions of a PBM’s P&T committee. In comparison to institutional formularies, PBMs have instituted tier-based formularies that encourage the use of more cost-effective agents to control prescription costs and improve therapy.^242,243 In spite of the economic influences on the P&T committee functions of a PBM, there is no end to opportunities for quality improvement by a PBM since there is no other organization that has the ability to access outpatient medication use to the same extent. Regardless of the organizational setting, the requirements for quality as a basis for decisions should be the chief focus of a P&T committee. Obviously, this is a potentially moving target because of the need to achieve a balance between the ethical standards involved in health care. The vested interests of the parent organization, patient’s needs and expectations, the professional activities of physicians, pharmacists and nurses, the pharmaceutical companies, and the requirements of society may be very difficult to reconcile.

National drug expenditure projection data, and the factors likely to influence drug costs for a particular year, can be reviewed by the P&T committee on a yearly basis. Also, it is necessary to keep hospital administrators informed of drug costs.²⁴⁴ An understanding of current trends is essential for formulary management.^245-247

LIAISON WITH OTHER ELEMENTS OF THE ORGANIZATION

Within any organization, it is often found that the root of problems is communications or, perhaps more often, a lack thereof. Unfortunately, the solution is not simply an increase in communication efforts in general. Instead, the need is for increasing appropriate communication, along with decreasing inappropriate communication. Some specific things have to be kept in mind.

First, make sure that everyone involved in any way in drug therapy receives some communication about medication-related matters.^160,248 Often, this may simply be a list of new drugs available being given to practitioners, along with any policies and procedures. Newsletters and educational presentations may also be valuable, depending on the circumstances. Electronic methods of communication are increasingly important, but the use of in-person counterdetailing may be necessary (see Chapter 23).¹³⁵

Second, be sure the amount of material is not overwhelming, otherwise it will be ignored. A news program on television a number of years ago described a situation that the military found regarding its pilots in Vietnam. They had a tape from the cockpit of an aircraft that had been shot down. Those listening to the tape could clearly hear the warning alarm letting the pilot know that a radar missile was locked on his aircraft and posing an imminent danger; however, it was also clear that the pilot did not even realize that warning was happening because of everything else going on. He mentally tuned out the warning and was shot down as a result. It became clear to those training pilots that it was necessary to limit the amount of information to whatever is most important, so that those items were noticed. This is also important in communicating P&T committee materials.

In addition, it is important to keep certain materials confidential for various reasons. In the case of quality assurance materials, keeping materials suitably confidential may protect that data from legal discovery in court (see Chapter 10 and consult attorneys for specifics). Also, some P&T committees keep the agenda and handouts confidential by not sending them to committee members in advance and by collecting the materials at the end of the meeting in order to destroy them. By doing so, they can often avoid pressure put on the committee by pharmaceutical company representatives, who may be trying to have their products included on the formulary, while having their competitor’s products excluded. The disadvantage, of course, is that committee members are not able to prepare for a meeting in advance. In relationship to this, it is often a good idea to make sure the pharmaceutical company representatives do not know the members of the committee and who is preparing the evaluation of a particular product, since that can lead to the evaluator being pressured to sway his or her opinion about a particular product. Many hospitals even fully ban pharmaceutical representatives from the hospital to avoid issues.

Finally, an annual report of the P&T committee may be prepared for both internal review and review by the medical executive committee. This annual report is time consuming in preparation but is a very important means of tracking P&T activities and actions over time.

Overall, it is necessary for the chair person and secretary of the P&T committee to work in cooperation with other appropriate individuals and groups to make sure that essential information is provided wherever needed, while minimizing the amount of extraneous material.

SYNCHRONIZATION OF DATABASES

Although it is more common to think of communication in regard to people, another important area of communications to be addressed is that between electronic databases. The pharmacy computer system may have to communicate with a whole hospital system or other computer systems. It is important to make sure all of these electronic systems are also synchronize, preferably automatically, although that may prove to be a problem.²⁴⁹

The pharmacy department can have a major impact on the quality of drug therapy in an institution through participation in P&T committee functions and activities described in this chapter; many of which are related to the management of information or are commonly performed by drug information practitioners. While there are many appropriate ways that may be used in addition to those outlined above, those described can be successfully used to improve drug therapy.

1. What is the P&T committee, what are its functions, and how does the committee relate to a pharmacy department?

2. How should a pharmacy/pharmacist be involved in supporting a P&T committee?

3. Define drug formulary and formulary system. How do those items relate to one another?

4. Define open versus closed formularies, including the specific types of closed formularies.

5. How does a P&T committee improve the quality of medication use in a hospital?

6. Define policy. Define procedure.

7. What are the steps in preparing a policy and procedure?

8. Name and briefly explain four policies and procedures that may be implemented by a P&T committee.

9. How does an institutional P&T committee differ from one in a PBM?

10. Who must a P&T committee communicate with? What should they communicate and how should they communicate?

11. What is considered a conflict of interest?

Debra Lee, PharmD, from Alegent Creighton Health Creighton University Medical Center is acknowledged for her assistance in preparing this chapter.