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Pharmacy Practice: Managing Formularies



Managing formularies

Managing formularies



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    Pharmacy Practice: Managing Formularies Pharmacy Practice: Managing Formularies Presentation Transcript

    • Managing Formularies ‫ دليل أدوية المستشفى‬Principles of a Sound Drug ‫الدكتور أنس البهنسي‬ Formulary SystemA.Bahnassi PhD RPh CDM 1Fall 2011
    • LEARNING OBJECTIVESAfter completing this lecture, students should beable to:1. Describe the purpose of a system in managing medication use in institutions.2. Discuss the organization and role of the pharmacy and therapeutics committee.3. Explain how formulary management works.4. List the principles of a sound formulary system.5. Define key terms in formulary management.A.Bahnassi Fall 2011 2
    • Formulary Management• Formulary – Definition: A continually updated list of medications and related information, representing the clinical judgment of physicians, pharmacists, and other experts in the diagnosis and/or treatment of disease and promotion of health.A.Bahnassi Fall 2011 3
    • Formulary Management• Formulary system management – Definition: An ongoing process whereby a health care organization, through its physicians, pharmacists, and other health care professionals, establishes policies on the use of drug products and therapies, and identifies drug products and therapies that are the most medically appropriate and cost-effective to best serve the health interests of a given patient population.A.Bahnassi Fall 2011 4
    • Formulary Management• Formulary system management – Theory: a well designed formulary can guide physicians to prescribe the safest and most effective agents for treatment of a particular condition.A.Bahnassi Fall 2011 5
    • Formulary Management• Objectives – Decrease drug cost – Assure high quality care – Provide information on drug products – Provide information on organizational policies/procedures – Development of institution specific guidelines/protocolsA.Bahnassi Fall 2011 6
    • Formulary Management• Purpose for ongoing management – Removal/addition of drugs from/to the market – Changes in hospital policies/procedures – New clinical information available • Clinical trials • Guidelines • SafetyA.Bahnassi Fall 2011 7
    • Formulary Management• Advantages • Disadvantages – Ensure quality and – Only reduces cost appropriateness of drug – Compromises patient use care – Educational for staff – Limits physician regarding most effective prescribing authority agents – Economic benefitsA.Bahnassi Fall 2011 8
    • Formulary Management• Principles – Drug product selection • Comparison of all aspects of an agent to that of similar medications. • Should be based on scientific evidence • Consider effectiveness, safety and costA.Bahnassi Fall 2011 9
    • Formulary Management• Principles – Formulary Maintenance • Addition/deletion – Newly approved agents – New information available (i.e. safety, efficacy) – Tracking use of nonformulary agents • Single drug review – Compare single drug to other drugs that are similar – Focus is on a single drug • Therapeutic class review – Compares/contrasts all the agents in a single class – Focus is not on a single drugA.Bahnassi Fall 2011 10
    • Drug Product Selection• Development of a drug monograph – Purpose: to evaluate various medications to ensure that patients receive drugs that are safe,therapeutically effective and cost effectiveA.Bahnassi Fall 2011 11
    • Drug Product Selection• Development of a drug monograph – Preparation • Identify drug to evaluate • Determine if there are similar agents on formulary • Obtain background information – Clinical and safety information – Indications – Cost – Clinical trialsA.Bahnassi Fall 2011 12
    • Drug Product Selection• Development of a drug monograph – Components • Summary page • Introduction • Pharmacology • Pharmacokinetics • Clinical efficacyA.Bahnassi Fall 2011 13
    • Drug Product Selection• Development of a drug monograph – Components (cont) • Adverse effects • Drug Interactions • Cost and dosage • Conclusion/Recommendations • ReferencesA.Bahnassi Fall 2011 14
    • Drug Product Selection• Points to consider – addition to formulary – Clinical effectiveness, safety, and cost – Comparison to similar agents – Comparison to standard therapies – Advantages/disadvantages – NicheA.Bahnassi Fall 2011 15
    • Drug Product Selection• Generic Substitution: – Definition: The substitution of drug products that contain the same active ingredient(s) and are chemically identical in strength, concentration, dosage form, and route of administration to the drug product prescribed. Approved Drug Products with Therapeutic Equivalence Evaluation the Orange Book http://www.accessdata.fda.gov/scripts/cder/ob/default.cfmA.Bahnassi Fall 2011 16
    • Drug Product Selection• Therapeutic Alternate: – Definition: Drug products with different chemical structures but which are of the same pharmacological and/or therapeutic class, and usually can be expected to have similar therapeutic effects and adverse reaction profiles when administered to patients in therapeutically equivalent doses.A.Bahnassi Fall 2011 17
    • Drug Product Selection• Therapeutic substitute: – Definition: The act of dispensing a therapeutic alternate for the drug product prescribed without prior authorization of the prescriber.This is an illegal act because only the prescribermay authorize an exchange of therapeuticalternates.A.Bahnassi Fall 2011 18
    • Drug Product Selection• Therapeutic Interchange – Definition: Authorized exchange of therapeutic alternates in accordance with previously established and approved written guidelines or protocols within a formulary system.A.Bahnassi Fall 2011 19
    • Drug Product Selection• Therapeutic interchange – Elements for successful implementation • P&T approval • Scientific/clinical evidence • Medical staff education • Mechanism to implement interchange • MaintenanceA.Bahnassi Fall 2011 20
    • Drug Product Selection – Therapeutic interchange process • Substitute generic for brand • Give individual agents in place of combination product • Switch from intravenous to oral antibiotics • Change to different agent in same class • Interchange may be automatic or may require notificationA.Bahnassi Fall 2011 21
    • Therapeutic Interchange• Advantages • Disadvantages – Reduced inventory – Confusing to patients – Hospital saves money – Patients may think that – Encourages compliance drugs are NOT equally with formulary effective – Preferred product may change based on contractsA.Bahnassi Fall 2011 22
    • Nonformulary AgentA medication that is not a part of the drugformulary. This may be due to the medicationnot being considered for formulary addition orthe medication being considered but the P&Tcommittee choosing not to add it.A.Bahnassi Fall 2011 23
    • Formulary Management Process Pharmacy Medical Staff Professional Staff Staff Medical Executive Committee Health System Board Drug Review Panel P&T Committee • Meets 6 times/yr • Review and act on recommendations Medication • Formulate Implementation Use Review Safety Committee Medical and Hospital Staff NotificationA.Bahnassi Fall 2011 24
    • Drug Review Panel • Focused on a particular specialty such as cardiology or infectious disease and review drug products and guidelines in their area of specialty. P&T CommitteeMedication Use Review Drug Safety Committee• Monitor one or more • Charged with review of medications use reviews, adverse drug events and evaluate the data and medication errors, their development plans to trending, and development optimize specific drug use. of plans for prevention. A.Bahnassi Fall 2011 25
    • Guiding Principles of a Sound DrugFormulary SystemFormulary system decisions are based onscientific and economic considerations thatachieve: Appropriate Safe and Cost-effective drug therapy.A.Bahnassi Fall 2011 26
    • Clinical decisions are based on Assessing peer-reviewed medical literature, including randomized clinical trials (especially drug comparison studies), pharmacoeconomic studies, and outcomes research data. Employing published practice guidelines, developed by an acceptable evidence-based process. Comparing the efficacy as well as the type and frequency of side effects and potential drug interactions among alternative drug products. Assessing the likely impact of a drug product on patient compliance when compared to alternative products. Basing formulary system decisions on a thorough evaluation of the benefits, risks, and potential outcomes for patients; risks encompass adverse drug events (adverse drug reactions and medication errors, such as those caused by confusing product names or labels).A.Bahnassi Fall 2011 27
    • Economic considerations include: Basing formulary system decisions on cost factors only after the safety, efficacy, and therapeutic need have been established. Evaluating drug products and therapies in terms of their impact on total health care costs. Permitting financial incentives only when they promote cost management as part of the delivery of quality medical care. Financial incentives or pressures on practitioners that may interfere with the delivery of medically necessary care are unacceptable.A.Bahnassi Fall 2011 28
    • P&T Committee MembershipEven though it is called the Pharmacy andTherapeutics committee, representation on thecommittee often includes physicians, nurses,and respiratory therapists given their roleswithin the medication use process. Thecollective efforts of all of the disciplines isneeded to achieve optimal health outcomes.A.Bahnassi Fall 2011 29
    • Responsibilities• Establishes and maintains the formulary system.• Selects medications for formulary inclusion by considering the relative clinical, quality of life, safety, and pharmacoeconomic outcomes. Decisions should be balanced to all of the above. Decisions should include consideration of continuity of care (e.g., local health plan formularies).• Evaluates medication use and related outcomes.• Prevents and monitors adverse drug reactions and medications errors.• Evaluates or develops and promotes use of drug therapy guidelines.• Develops policies and procedures for handling medications to include their procurement prescribing, distribution, and administration.• Educates health professionals to the optimal use of medications.A.Bahnassi Fall 2011 30
    • Formulary System MaintenanceThe committee develops a list of medications foruse in the organization. They may also developguidelines for the optimal use of themedications and/or for specific diseasemanagement.They review the medication list and guidelineson a regular basis to assure that it is current andmeets the needs of the medical staff andpatients.A.Bahnassi Fall 2011 31
    • Medication Selection and ReviewThe committee should have established methods formedication selection and review.A written medication review is prepared from availableliterature.The review should be unbiased, as should the discussionof the review.Meeting participants (committee members and guests)should be required to discuss any conflict of interestsprior to discussion of the drug or drug class.Medication selection criteria should include medicationefficacy, safety, and cost.A.Bahnassi Fall 2011 32
    • Barriers to Optimal Formulary Decisions Physicians experience with the drug under consideration. Physicians preference of other agents. Detailing by pharmaceutical representatives. Unpublished or anecdotal studies and reports. Selection criteria should be such to minimize these barriersA.Bahnassi Fall 2011 33
    • Medication Safety EvaluationMedication safety is evaluated through adversedrug reactions reports, and medication errorsreports. These reports can be local or global. The impact of these reports should be considered relative to the health system population, resources, and alternatives.A.Bahnassi Fall 2011 34
    • Drug Therapy GuidelinesListing of the indications, dosage regimens,duration of therapy, mode(s) of administration,monitoring parameters and special considerationsfor use of a specific medication or medication class. These guidelines are developed with the oversight of practitioners with expertise in the use of a specific medication or management of a disease state. The guidelines are often put into practice via a pre-printed physician order sheet placed in the patient chart or computerized order set.A.Bahnassi Fall 2011 35
    • Drug Therapy Guidelines The development of drug therapy guidelines is often the result of a medication use review or medication safety evaluation. A review of this data may indicate that the drug is not being used in an optimal manner with regard to patient selection, dosage, frequency, route, length of therapy, or a combination. The development and implementation of drug therapy guidelines may foster the safe, efficacious and cost effective use of selected drug products. Education of the professional and medical staff to these guidelines is critical to their success. Just as important is a method for routine review of the guidelines to assure they are current.A.Bahnassi Fall 2011 36
    • Policy and Procedure Development The development of guidelines on historically pharmacy related topics of medication procurement, selection, and distribution. Medication administration process which includes determining what medications are administered in specific locations for the hospital (i.e., intensive care unit) or under specific conditions (i.e., by chemotherapy certified nurse). Finally, they define the formulary management process, specifically, guidelines for the evaluation of medications by the P&T committee, frequency of such review, maintenance of the medication list, etc…A.Bahnassi Fall 2011 37
    • Education The P&T committee must communicate its actions to health-system staff and physicians. A newsletter is often employed to communicate these decisions. The newsletter may also include clinical information on drugs added to the formulary, drug therapy guidelines developed, and medication safety information available. The success of a newsletter may be limited by the format and content.A.Bahnassi Fall 2011 38
    • The pharmacist role in the formularymanagement process Establish P&T committee meeting agenda. Analyze and disseminate scientific, clinical, and health economic information regarding a medication or therapeutic class for review by the P&T committee. Conduct drug use evaluation and analyze data. Record and archive P&T committee actions. Follow-up with research when necessary. Communicate P&T committee decisions to other health care professionals such as pharmacy staff, medical staff, and patient care staff.A.Bahnassi Fall 2011 39
    • A list of medications which has no limitation to access Open to a medication by a Formulary practitioner.Formularies A list of medications which limits access of a Closed practitioner to some medications. It may limit Formulary drugs to specific physicians, patient care areas, or disease states via formulary restrictions. A.Bahnassi Fall 2011 40
    • Formulary Restriction: The act of limiting the use of specific formulary medications to specific physicians based on areas of expertise (e.g., cardiology), patient disease state (e.g., acute myocardial infarction), or location (e.g., operating room).A.Bahnassi Fall 2011 41
    • Guidelines to generic and therapeuticinterchange The pharmacist is responsible for selecting generically equivalent products in concert with FDA regulations. Prescribers may specify a specific brand if clinically justified. The decision should be based on pharmacologic and/or therapeutic considerations relative to the patient. The P&T committee determines therapeutic equivalents and how they are processed.A.Bahnassi Fall 2011 42
    • Formulary MaintenanceThe ongoing process of assuring relative safety andefficacy of agents available for use in the health-system.Processes used in formulary maintenanceinclude the following: New product evaluation Therapeutic class review Formulary changes (rationale for retaining or deleting an agent from the formulary) Nonformulary drug use reviewA.Bahnassi Fall 2011 43
    • New Product EvaluationPharmacists have the opportunity to assume aleadership role in the selection of agents to theformulary.A.Bahnassi Fall 2011 44
    • Drug Utilization ReviewProcess used to assess the appropriateness ofdrug therapy by engaging in the evaluation ofdata on drug use in a given health careenvironment against predetermined criteria andstandards.A.Bahnassi Fall 2011 45
    • Drug Use Evaluation (DUE) vs. Medication Use Evaluation (MUE) • A systematic process used to assess the appropriateness of drug therapy by engaging in the evaluation of data on drug use in a given health care environment against predetermined criteria and standards. Medication use evaluation (MUE) encompasses the goals and objectives of DUE in its broadest application, with an emphasis on improving patient outcomes. • Use of MUE rather than DUE emphasizes the need for a more multifaceted approach to improving medication use.The differences between MUE, DUE, and outcomes assessment are arbitrary.Nevertheless, these definitions have evolved in response to a tendency for somepharmacists to only see medication use as it relates to the world of pharmacy. Therefore,compliance with formulary restrictions, pharmacy policies and procedures, and otherprocesses are sometimes emphasized over the actual outcomes achieved by patients.Redefining terminology can refocus efforts of medication use evaluation toward achievingthe goal of positive patient outcomes. A.Bahnassi Fall 2011 46
    • Drug Use EvaluationFOCUS-PDCA Find process to improve  Plan Organize a team that knows the process  Do Clarify current  Check (or Study) knowledge of the  Act process Understand causes of process variation Select process improvementA.Bahnassi Fall 2011 47
    • Antibiotic Prophylaxis for Surgery Patients (PDCA Model)A.Bahnassi Fall 2011 48
    • Summary• The pharmacist plays a critical role in the management of medication use in the health- system.• As the drug expert, the pharmacist can assure safe, efficacious, and cost effective drug use through the formulary system.• Ongoing formulary maintenance and routine drug use evaluations are key elements in this process.• Focused consideration of medication safety in all medication related discussions optimizes formulary system management.A.Bahnassi Fall 2011 49