pharmacy practice: managing formularies

Managing Formularies Principles of a Sound Drug Formulary System

A.Bahnassi PhD RPh CDM Fall 2011

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دليل أدوية المستشفى الدكتور أنس البهنسي

LEARNING OBJECTIVES

After completing this lecture, students should be able 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.



• 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.



• 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.



• Objectives

– Decrease drug cost

– Assure high quality care

– Provide information on drug products

– Provide information on organizational policies/procedures

– Development of institution specific guidelines/protocols



• Purpose for ongoing management

– Removal/addition of drugs from/to the market

– Changes in hospital policies/procedures

– New clinical information available

• Clinical trials

• Guidelines

• Safety



• Advantages

– Ensure quality and appropriateness of drug use

– Educational for staff regarding most effective agents

– Economic benefits

• Disadvantages

– Only reduces cost

– Compromises patient care

– Limits physician prescribing authority



• 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 cost



• 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 drug


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 effective



• 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 trials




– Components

• Summary page

• Introduction

• Pharmacology

• Pharmacokinetics

• Clinical efficacy




– Components (cont)

• Adverse effects

• Drug Interactions

• Cost and dosage

• Conclusion/Recommendations

• References



• Points to consider – addition to formulary

– Clinical effectiveness, safety, and cost

– Comparison to similar agents

– Comparison to standard therapies

– Advantages/disadvantages

– Niche



• 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.cfm A.Bahnassi Fall 2011 16

http://www.accessdata.fda.gov/scripts/cder/ob/default.cfm




• 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.



• 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 prescriber may authorize an exchange of therapeutic alternates.



• Therapeutic Interchange

– Definition: Authorized exchange of therapeutic alternates in accordance with previously established and approved written guidelines or protocols within a formulary system.



• Therapeutic interchange

– Elements for successful implementation

• P&T approval

• Scientific/clinical evidence

• Medical staff education

• Mechanism to implement interchange

• Maintenance



– 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 notification


Therapeutic Interchange

• Advantages

– Reduced inventory

– Hospital saves money

– Encourages compliance with formulary

• Disadvantages

– Confusing to patients

– Patients may think that drugs are NOT equally effective

– Preferred product may change based on contracts


Nonformulary Agent

A medication that is not a part of the drug formulary. This may be due to the medication not being considered for formulary addition or the medication being considered but the P&T committee choosing not to add it.


Formulary Management Process

Pharmacy Staff

Medical Staff Professional Staff

Medical Executive Committee Health System Board

P&T Committee • Meets 6 times/yr • Review and act on

recommendations • Formulate Implementation

Drug Review Panel

Safety Committee

Medical and Hospital Staff Notification

Medication Use Review


P&T Committee

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.

Drug Safety Committee

• Charged with review of adverse drug events and medication errors, their trending, and development of plans for prevention.

Medication Use Review

• Monitor one or more medications use reviews, evaluate the data and development plans to optimize specific drug use.


Guiding Principles of a Sound Drug Formulary System

Formulary system decisions are based on scientific and economic considerations that achieve:

Appropriate

Safe and

Cost-effective drug therapy.


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).


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.


P&T Committee Membership

Even though it is called the Pharmacy and Therapeutics committee, representation on the committee often includes physicians, nurses, and respiratory therapists given their roles within the medication use process. The collective efforts of all of the disciplines is needed to achieve optimal health outcomes.


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.


Formulary System Maintenance

The committee develops a list of medications for use in the organization. They may also develop guidelines for the optimal use of the medications and/or for specific disease management.

They review the medication list and guidelines on a regular basis to assure that it is current and meets the needs of the medical staff and patients.


Medication Selection and Review

The committee should have established methods for medication selection and review.

A written medication review is prepared from available literature.

The review should be unbiased, as should the discussion of the review.

Meeting participants (committee members and guests) should be required to discuss any conflict of interests prior to discussion of the drug or drug class.

Medication selection criteria should include medication efficacy, safety, and cost.


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 barriers


Medication Safety Evaluation

Medication safety is evaluated through adverse drug reactions reports, and medication errors reports.

These reports can be local or global.

The impact of these reports should be considered relative to the health system population, resources, and alternatives.


Drug Therapy Guidelines

Listing of 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. 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.


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.


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…


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.


The pharmacist role in the formulary management 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.


Formularies

Open Formulary

Closed Formulary

A list of medications which has no limitation to access

to a medication by a practitioner.

A list of medications which limits access of a

practitioner to some medications. It may limit

drugs to specific physicians, patient care areas, or

disease states via formulary restrictions.


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).

Formulary Restriction:


Guidelines to generic and therapeutic interchange

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.


Formulary Maintenance

The ongoing process of assuring relative safety and efficacy of agents available for use in the health-system. Processes used in formulary maintenance include the following: New product evaluation Therapeutic class review Formulary changes (rationale for retaining or

deleting an agent from the formulary) Nonformulary drug use review


New Product Evaluation

Pharmacists have the opportunity to assume a leadership role in the selection of agents to the formulary.


Drug Utilization Review

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.


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 some pharmacists to only see medication use as it relates to the world of pharmacy. Therefore, compliance with formulary restrictions, pharmacy policies and procedures, and other processes are sometimes emphasized over the actual outcomes achieved by patients. Redefining terminology can refocus efforts of medication use evaluation toward achieving the goal of positive patient outcomes.


Drug Use Evaluation FOCUS-PDCA Find process to improve

Organize a team that knows the process

Clarify current knowledge of the process

Understand causes of process variation

Select process improvement

Plan

Do

Check (or Study)

Act


Antibiotic Prophylaxis for Surgery Patients (PDCA Model)


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.
