Introduction to Hospital and Health-System Pharmacy Practice 59 Tients with a Specific Disease State Or for Activities Related to Self Governance Diagnosis

Part II: Managing Medication Use CHAPTER 4 Medication Management Kathy A. Chase ■■ ■■■ Key Terms and Definitions Learning Objectives ■■ Closed formulary: A list of medica- After completing this chapter, readers tions (formulary) which limits access should be able to: of a practitioner to some medications. 1. Describe the purpose of a formulary A closed formulary may limit drugs to system in managing medication use in specific physicians, patient care areas, or institutions. disease states via formulary restrictions. 2. Discuss the organization and role of the ■■ Drug formulary: A formulary is a pharmacy and therapeutics committee. continually updated list of medications 3. Explain how formulary management and related information, representing works. the clinical judgment of pharmacists, 4. List the principles of a sound formulary physicians, and other experts in the system. diagnosis and/or treatment of disease 5. Define key terms in formulary manage- and promotion of health. ment. ■■ Drug monograph: A written, unbi- ased evaluation of a specific medication. This document includes the drug name, therapeutic class, pharmacology, indications for use, summary of clinical trials, pharmacokinetics/dynamics, adverse effects, drug interactions, dosage regimens, and cost. ■■ Drug therapy guidelines: A document describing the indications, dosage regimens, duration of therapy, mode(s) of administration, monitoring parameters and special considerations for use of a specific medication or medication class. ■■ Drug use evaluation (DUE): A process used to assess the appropriate- ness of drug therapy by engaging in the evaluation of data on drug use in a given health care environment against predetermined criteria and standards. ◆■ Diagnosis-related DUE: A drug use evaluation completed on pa- INTRODUCTION TO HOSPITAL AND HEALTH-SYSTEM PHARMACY PRACTICE 59 tients with a specific disease state or for activities related to self governance diagnosis. An example is the use of and for performance improvement of antibiotics in patients with commu- the professional services provided by all nity acquired pneumonia. practitioners privileged through medi- ◆■ Prescriber-related DUE: A drug cal staff process. use evaluation completed on ■■ Medication use review: A perfor- patients managed by a specific mance-improvement method that physician or physician group. For focuses on evaluating and improving example, selected antibiotics may be medication-use processes with the goal limited to infectious disease spe- of optimal patient outcomes. cialists or drotrecogin alfa may be ■■ Nonformulary agent: A medication limited to critical care specialists. that is not a part of the drug formulary. ◆■ Drug-specific DUE: A drug use This may be due to the medication not evaluation completed on a drug being considered for formulary addi- (medication). tion or the medication being consid- ■■ FOCUS-PDSA: A performance ered but the P&T committee choosing improvement model used by hospitals not to add it. and health-systems. It includes the ■■ Open formulary: A list of medications performance improvement elements (formulary) which has no limitation to of measuring the output of the process access to a medication by a practitioner. and modifying the process to improve ■■ Order entry rules: Logic established the outcome. within the hospital information system ■■ Formulary restriction: The act of order entry module to notify prescrib- limiting the use of specific formulary ers of adverse effects, drug interactions, medications to specific physicians monitoring required or other actions based on areas of expertise (e.g., cardi- required. ology), patient disease state (e.g., acute ■■ Outcome assessment: A systematic myocardial infarction), or location process of evaluating the appropriate- (e.g., operating room). ness, safety and efficacy of a medica- ■■ Formulary system: An ongoing tion. The process involves review of process whereby a health care organi- patient medical records to evaluate the zation, through its physicians, phar- drug use against predetermined criteria macists, and other health care profes- and standards. sionals, establishes policies on the use ■■ Pop-ups: Information that appears of drug products and therapies and on a computer monitor when specific identifies drug products and therapies actions are taken. Hospital information that are the most medically appropri- systems often use rules to determine ate and cost-effective to best serve when pop-ups will occur. These pop-ups the health interests of a given patient may contain clinical information about population. medication use, potential drug interac- ■■ Health-system board: A committee tions, recommended monitoring, etc. of hospital and community members ■■ Stop orders: Physician orders that are chosen to govern the affairs of hospital automatically terminated. The P&T or health-system. committee may establish stop orders ■■ Medical executive committee: A for medications that require additional committee of the hospital medical evaluation after a specific time. Ex- staff that has the primary authority amples of stop orders are antibiotic 60 CHAPTER 4: MEDICATION MANAGEMENT therapy stopped after 7 days and nesir- but of the same pharmacologic or ther- itide therapy stopped after 24 hours. apeutic class and usually having similar ■■ Therapeutic class review: An evalu- therapeutic effects and adverse-reaction ation of a group of medications with profiles when administered to patients an established therapeutic class (e.g., in therapeutically equivalent doses. first-generation cephalosporins). The ■■ Therapeutic interchange: Authorized review evaluates the indications for use, exchange of therapeutic alternatives in pharmacokinetics/dynamics, adverse accordance with previously established effects, drug interactions, dosage regi- and approved written guidelines or mens, and cost to determine similarities protocols within a formulary system. and differences. ■■ Therapeutic equivalent: Drug products with different chemical structures ■■ ■■■ Introduction Medication use management describes the process used to assure the safe and effective use of drugs in a cost conscious manner. Key to medication management in the health- system environment is the formulary system. The formulary system is a mechanism for ongoing assessment of medications that are available for use. The system is managed by a committee of experts, which includes pharmacists and physicians. This chapter will discuss the medication management system with focus on the fol- lowing: ■■ Formulary system ■■ Pharmacy and therapeutics committee ■■ Formulary management ■■ Drug use evaluation ■■ Medication use policies ■■ Published formulary The Formulary System A drug formulary is a continually updated list of medications and related information, representing the clinical judgment of pharmacists, physicians, and other experts in the diagnosis and/or treatment of disease and promotion of health. It is often described as a list of medications routinely stocked by the health care system. The formulary was devel- oped by hospitals in the 1950s as a management tool. It was initially used to assure that physicians had an adequate and consistent supply of medications for their day-to-day needs. A key purpose of the formulary was to discourage the use of marginally effective drugs and treatments. Over time, the formulary has evolved beyond a simple list of medications. It is now one element of a system that includes medication use policies, a pharmacy and therapeutics committee, medication use evaluation, and formulary management. The formulary, today, can be more accurately defined as a continually updated list of medications and related information, representing the clinical judgment of pharmacists, physicians, and other experts in the diagnosis and/or treatment of disease and promotion of health. INTRODUCTION TO HOSPITAL AND HEALTH-SYSTEM PHARMACY PRACTICE 61 Formularies are fundamental to the formulary system—defined as an ongo- ■■ ■■■ ing process which methodically evaluates Key Point . medications on an ongoing basis for inclu- sion or exclusion, establishes guidelines The formulary has evolved beyond a list of for optimal medication use, and develops medications to a system that manages the policies and procedures for prescribing, drug use process. dispensing, and administering medications. The formulary system is managed by . So what? the pharmacy and therapeutics committee Standard definitions of formularies refer or equivalent group—made up of an orga- to them as static compilations of recom- nized team of medication system experts. There are advantages and disadvan- mended medications in a pharmacy. In tages to a formulary system. The primary truth, they are really dynamic entities advantage is that it provides a systematic that consist of a constantly changing method to review scientific evidence on medication list, policies and procedures clinical effectiveness and cost effectiveness for managing that list, and tools used to in drug selection decision, thus potentially improving health outcomes while reducing encourage appropriate use of medications costs. A major disadvantage, however, is on that list—e.g., therapeutic substitution, that an overly restrictive formulary system drug utilization review). may potentially reduce the quality of care by limiting access to clinically indicated medications. The Pharmacy and Therapeutics Committee The pharmacy and therapeutics committee (P&T committee) has oversight for medication management

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