MEDICATION-MANAGEMENT.pptx

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CHAPTER 4: MEDICATION MANAGEMENT

Key Terms and Definitions› Closed formulary: limits access of a practitioner to some medications

› Drug formulary: continually updated list of medications and related information

› Drug monograph: written, unbiased evaluation of a specific medication

› Drug therapy guidelines: describes the indications, dosage regimens, duration of therapy, mode of administration, monitoring parameters and special considerations for use of a specific medication

› Drug use evaluation (DUE): used to assess the appropriateness of drug therapy– Diagnosis-related DUE: completed on patients with specific disease state or diagnosis– Prescriber-related DUE: completed on patients managed by specific physician or physician group– Drug-specific DUE: completed on a drug

› FOCUS-PDSA: performance improvement model used by hospitals and health-systems

› Formulary restriction: act of limiting use of specific formulary medications

› Formulary system: process whereby a health care organization establishes policies on the use of drug products and therapies

Key Terms and Definitions› Health-system board: governs the affairs of hospital or health-system

› Medical executive committee: has primary authority for activities related to self governance and for performance improvement of professional services

› Medication use review: focuses on evaluating and improving medication-use processes

› Nonformulary agent: not part of drug formulary

› Open formulary: no limitation to access to a medication by practitioner

› Outcome assessment: systematic process of evaluating the appropriateness, safety, and efficacy of medication

› Pop-ups: appears on computer monitor when specific actions are taken

› Stop orders: physician orders that are automatically terminated

› Therapeutic class review: evaluation of group of medications with an established therapeutic class

› Therapeutic equivalent: drug products with different chemical structures but of same pharmacologic or therapeutic class and usually having similar therapeutic effects and adverse reaction

› Therapeutic interchange: authorized exchange of therapeutic alternatives

This describes the process used to assure the safe and effective use of drugs in a cost conscious manner

Key to medication management system environment is the formulary system.

What is Medication Use Management?

The Formulary System › This is a mechanism for ongoing assessment

of medications that are available for use

› Managed by a committee of experts which includes pharmacists and physicians.

The Drug Formulary› This refers to a continually updated list of medication

representing the clinical judgment of health care experts.

› List of medications routinely stocked by the health care system

› Developed in the hospitals in the 1950’s as a management tool

› Initially used to ensure adequate drug supply for physicians

› Key purpose was to discourage the use of marginally effective drugs and treatment

› Has evolved beyond a simple list of medications– Now an element of system that includes medication use policies, P&T

committee, medication use evaluation, and formulary management.

Importance of Formularies› It methodically evaluates medications on an

ongoing basis for inclusion or exclusion

› It establishes guidelines for optimal medication use

› It develops policies and procedures for prescribing, dispensing and administering medications

Advantages and Disadvantages of a Formulary System› Advantages:

– Provides systematic method to review scientific evidence on clinical effectiveness and cost effectiveness in drug selection decision

– Potentially improves health outcomes while reducing cost

› Disadvantages:– An overly restricted formulary system may potentially

reduce the quality of care by limiting access to clinically indicated medications

Pharmacy and Therapeutics Committee (P&T)› Manages the formulary system

› Has oversight of medication management in the health system

› Generally a policy recommending body to the medical staff through the medical executive committee.

› A group of the hospital medical staff in charge of institutional governance and performance.

› Has reported directly to a non-medical staff advisory committee of hospital and community members called a health-system board.

› Meetings should occur at least four to six times per year. Generally, monthly meetings are needed to keep the meeting time to 60-90 minutes.

› Subcommittees or task forces have been established to facilitate meeting efficiency.– Medication safety– Drug review panels– Medication use review

Pharmacy and Therapeutics Committee (P&T)

Medication Safety Task Force› Charged with review of adverse drug events and

medication errors, their trending and development of plans for prevention of future events.

Drug Review Panels› Focused on a particular specialty such as

cardiology or infectious disease and review drug products and guidelines in there area of specialty.

Medication Use Review Task Force› Monitor one or more medications use reviews, evaluate

the data and development plans to optimize specific drug use.

› It is important to establish rules for a quorum to make certain that the key stakeholders are represented at meetings.

› Establish a minimum number of members that must be present to conduct a meeting

› Establish a minimum number of member types that must be present to conduct a meeting.– E.g. a committee with 15 members might be required to

have at least five members present to which two must be physician and one must be a pharmacist before a quorum has been established.


Committee Membership› Should include pharmacists, nurses, physicians, administrators, risk or quality improvement managers, and others as appropriate.

› It should include nonphysician members because the medication management is a multidisciplinary process.


RESPONSIBILITIES:

The committee performs the following functions:

› Establishes and maintains the formulary system.

› Selects medications for formulary inclusion by considering the following:– Relative clinical– Quality of life– Safety– Pharmacoeconomic outcomes


Pharmacy and Therapeutics Committee (P&T)RESPONSIBILITIES:

› Evaluates medication use and related outcomes.

› Prevents and monitors adverse drug reactions and medication errors.

› Evaluates or develops and promotes use of drug therapy guidelines.

› Develops policies and procedures for handling medications

› Educates health professionals to the optimal use of medications.

Formulary System Maintenance› The committee develops a list of medications for

use in the organization.

› 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.

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.

› Meeting participants should be required to discuss any conflict of interests prior to discussion of the drug or drug class.

Medication Selection Criteria: Is it a duplication of an existing formulary agent?

If so, is it more effective? Safer? Less costly?How should it be used?When should it be used?Who should use it?Are there any other special concerns?

Medication Selection and Review

Barriers to Optimal Formulary Decisions:

› Physician experience with the drug under consideration

› Physician preference for other agents

› Detailing by pharmaceutical company representatives

› Unpublished or anecdotal studies and reports

Medication Selection and Review

Medication Use Evaluation› Method for evaluating and improving medication-

use process with the goal of optimal patient outcomes.

› Medications may be considered for review based on the following:– Use– Safety– Cost– Combination of factors

Foundation of the Medication-Use Process:

› Establishment of specific criteria for use

› Review for compliance to the criteria

› Routine review of the data

Medication Use Evaluation

*Key to the process is timely data to review, action plan development, and follow-up.

› Medication safety is evaluated through adverse drug reaction reports and medication error reports.– LOCAL: from the health system– GLOBAL: from literature or press releases

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

Such reports should be used in considering whether a drug should be added to the formulary, retained on the formulary, or deleted from the formulary.

Medication Safety Evaluation

› 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.

› They are often put into practice via a pre-printed physician order sheet placed in the patient chart or computerized order set.

› The development of the guidelines is often the result of a medication use review or medication safety evaluation.

Drug Therapy Guidelines

› The development and implementation of these guidelines may foster the safe, efficacious and cost effective use of selected drug products.

› Just as important is a method for routine review of the guidelines to assure they are current.

Drug Therapy Guidelines

› The P&T committee is responsible for the medication use in the hospital. This includes the development of guidelines on historically pharmacy related topics of medication procurement, selection and distribution.

› They are also responsible for the medication administration process. – determining what medications are administered in

specific locations for the hospital (intensive care unit)– Under specific conditions (chemotherapy certified

nurse)

Policy and Procedure Development

› 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.

Policy and Procedure Development

› The P&T committee must communicate its actions to health-system staff and physicians.

NEWSLETTER:

› Often employed to communicate different decisions of the committee.

› May also include clinical information on drugs added to the formulary, drug therapy guidelines developed, and medication safety information available.

Education

NEWSLETTER:

› Its success may be limited by the format and content.

› It should be visually pleasing, easy to follow and succinct.

› It should be limited to two to four pages in length.

› The audience is generally broad and includes physicians, nurses, pharmacists, and other health-care professionals.

Education

Education

Other methods to communicate and educate others to P&T committee actions:

› Presentation at medical staff department meetings

› Nursing unit staff meetings

› Pharmacy staff meetings

› Electronic messaging (e.g. through email or the health-system website)

Education

› May require a P&T committee and define its membership and responsibilities

Regulatory and Accrediting Bodies

REGULATORY BODIES

› State Department of Health

› Board of Pharmacy

› Varies by state

ACCREDITING BODIES

› The Joint Commission

› American Osteopathic Association (AOA)

› Commission on Accreditation of Rehabilitation Facilities (CARF)

› Facility type will define the accrediting body

› Each has a slightly different interpretation of the term formulary.

› Regulations and accreditation standards are dynamic and require vigilance by the pharmacy to assure compliance.

Regulatory and Accrediting Bodies

Pharmacist Role› Pharmacists are essential to the formulary

management process.

› They will often guide the P&T committee activities to assure optimal medication management.

Pharmacist RolePharmacist responsibilities may include the following:

› Establish P&T committee meeting agenda.

› Analyse and disseminate scientific, clinical and health economic information

› Conduct drug use evaluation and analyse data.

› Record and archive P&T committee actions.

› Follow-up with research when necessary.

› Communicate P&T committee decisions to other health-care professionals.

Formulary Management

›patient care medication efficacy and safety

›financial implications cost of the drug costs associated with stocking the medication

(shelf space, drug outdates, and handling)

›OPEN FORMULARY

- no limitation to access to a medication

- Generally large

›CLOSED FORMULARY

- limited list of medications

- may limit drugs to specific physicians, patient care areas, or disease states via formulary restrictions

FORMULARY RESTRICTIONS

*do not necessarily translate to optimal medication management

---Formulary restrictions often have unintended consequences(e.g.

Antibiotic Resistance)

• Drug product selection should be based on individual chemical entities

› Approved Drug Products with Therapeutic Equivalence Evaluation

- ”Orange Book”

- where the list of the generic equivalents is found

Therapeutic Interchange

- drug products with different chemical structure but are of the same pharmacologic and/or therapeutic class

- expected to have similar therapeutic effects and adverse effects

Therapeutic Equivalents

- authorized exchange of therapeutic alternatives in accordance with previously established and approved written guideline

Examples of therapeutic interchanges

Guidelines for generic substitution and therapeutic interchange› Pharmacist is responsible for selecting generically

equivalent products in concert with FDA regulations

› Prescribers may specify a specific brand if clinically justified

※ 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

Pharmacist is responsible for the:

› Quality

› Quantity

› Source of all medications

› Biologicals and pharmaceutical preparations used in the diagnosis and treatment of patients

FORMULARY MAINTENANCE› ongoing process of assuring relative safety and

efficacy of agents available for use in the health-system

PROCESS: 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

The evaluations of an agent should consider:

- indications for use - pharmacokinetics - safety - cost

Considerations to:- drug storage- mode of administration- special considerations- drug dispensing issues

Standard elements include the following:

Generic name Trade name Therapeutic or pharmacologic class Pharmacology Pharmacokinetics Indications for use Clinical study

Standard elements include the following:

Adverse effects/warnings Drug interactions Dosage range Dosage forms and cost Summary Recommendation References

THERAPEUTIC CLASS

REVIEW

The objective is to have the optimal agents within a therapeutic class in terms of efficacy, safety, and cost.

The end result of a therapeutic class review may be formulary modifications, implementation of a drug use review or the development of therapeutic guidelines.

FORMULARY CHANGES A process to continually update the formulary

involves the submission of a request for formulary addition or deletion from the pharmacy or medical staff. Requests generally require specific information.

- agent to be considered for addition/deletion- rationale for request- alternative agents currently on the formulary

NONFORMULARY DRUG REVIEW

Nonformulary agent

-A medication that is not 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.

- 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.

Drug use evaluation (DUE)

⁞ First established in the 1980s⁞ An ongoing, structured, organized approach to ensure

that drugs are used appropriately⁞ outcome assessment has been used to describe

such programs⁞ The desired endpoint is safe, efficacious drug

therapy

DRUG USE and MEDICATION USE

EVALUATION

***Medication use evaluation programs should be incorporated into the overall hospital performance improvement process

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

FOCUS-PDCA

› Pharmacists can take a leadership role in designing the drug use evaluation programs.

› The program should measure and compare the outcomes of patients who received drug therapy in concert with approved criteria versus those that did not.

› Selection of agents for drug use evaluation programs should be based on whether a drug is high-use, high-cost, or high-risk.

› Pharmacists, working with key physicians, develop criteria for drug use evaluation.

Medication Use Criteria

Drug-specific DUE criteria

› identify indications for which select drug(s) may be appropriate for a given disease state

Prescribers-related DUE criteria

Diagnosis-related DUE criteria

› identify specific physicians whom the P&T committee has determined may use certain drugs

› focus on specific aspects of a select drug such as the dose or dosing frequency

› The criteria should be focused and limited.

› Select three to five criteria to evaluate that are meaningful and simple to collect.

› If possible, data should be collected during the patient visit (concurrent) rather than retrospectively (chart review).

› The criteria should also include a number of patients to be reviewed and the time period.

› The drug use evaluation criteria are presented to the P&T committee for their review and endorsement prior to commencing data collection.

Develop Criteria for Drug Use Evaluation

› Technology may be used to collect or screen data. Use of information systems to identify patients for review and

collate the data will facilitate the process. Handheld computers or personal data assistants (PDAs) may be

useful in the data collection process.

› Once the data has been collected, it should be compiled for review. The use of trend graphs or control charts are helpful in identifying

opportunities for improvement.

› Once the data is collated, it may be beneficial to form a task force to develop an action plan and criteria for ongoing monitoring The action plan may include development of drug use guidelines,

pre-printed orders, medication order entry rules, professional staff education, formulary changes, or a combination of these actions


› The drug use evaluation results and action plan are presented to the P&T committee for consideration. A single drug use evaluation should not continue

indefinitely.

› Once the desired endpoint has been achieved, an ongoing review may be discontinued or conducted less frequently


Pharmacy and Therapeutics Committee

› The policy should address the committee membership, operation, and responsibilities

Medication Prescribing, Dispensing, and

Administration› Writing medication orders or prescriptions –

defines practitioners that may write medication orders or prescriptions in concert with state and federal regulations. This or related policies may also include the format for order writing and unacceptable abbreviations.

› Verbal orders – defines who may accept a verbal order and the transcription process of such an order. This policy should address the reading back of the order to confirm its accuracy

› Stop orders – defines the orders that are automatically terminated, how the prescriber is notified, if appropriate, and the method for their reinstatement

› Investigational drug orders – defines how investigational drugs are managed in the health care system. This policy should include the review process as well as the method for prescribing, dispensing, administering, and monitoring investigational agents


Administration


Administration› Controlled substances – defines the flow of controlled

substances through the health care system. This policy should include approved prescribers, the ordering process from the pharmacy and the vendor, the distribution and tracking of use, discrepancy tracking and follow-up, and management of diversion.

› Generic and therapeutic substitution – defines how a drug is selected for generic substitution and therapeutic equivalents approved by the P&T committee. It should describe how an alternative agent may be prescribed if deemed medically necessary.

› Self-administration of medications – defines the conditions and process for the administration of medication by the patient in the hospital setting.

› Medication samples – defines the conditions and process for the use of medication samples in the hospital or clinic setting

› Floor stock – defines the criteria for selecting agents for floor stock, process for modifying the stock, and the regular review of the stock by the P&T committee.

› Definition of order interpretation – defines the meaning of specific types of orders including sliding scale orders, range orders, as needed orders, tapering orders, and titrating orders.


Administration


Administration› Medication administration times – defines specific

medication administration times and rules for interpretation. This may include the definition of stat and related terminology.

› Adverse drug reactions – defines an adverse drug reaction, the reporting process, and monitoring methods.

› Medication errors – defines a medication error, the reporting process, and monitoring methods.

› Other – include pharmaceutical representatives, pharmacy hours of service, emergency medications, and medication delivery devices.

PUBLISHED FORMULARY

It should provide:– information on the medications approved for use– basic therapeutic information about each item– information on medication use policies and procedures– special information about medications such as dosing guidelines

MEDICATION LIST› It is the key element of the published formulary.

› It includes both entries for each medication and indexes to facilitate use.

› May be arranged alphabetically by generic name and trade name, therapeutic class, or a combination.

› The list should include one or more indexes

One type of index is by using generic name or both generic and trade name.

The second type is the therapeutic index which arranges drugs generically by therapeutic or pharmacological class (useful for prescribers not familiar with the formulary of a health-system and desires to prescribe a certain type of drug).

The following should be included in each drug entry:

› generic name of primary active ingredient

› trade or synonym name that is commonly used

› dosage form, strength, and size stocked by the pharmacy

› active ingredients (formulation) for combination products

These are additional information that can be added:

› DEA schedule (C-II through C-V)

› special precautions

› pediatric or adult dosage ranges

›Cost information

MEDICATION USE POLICY AND PROCEDURES

Inclusion of information on the prescribing, dispensing, and administration of medications for a quick reference.

Policies for inclusion are the

› formulary policy

› P&T committee policy

› organizational regulations regarding medication use Information on pharmacy operating procedures may be

beneficial (hours of services, prescription policies, medication distribution procedures, contact information, and other pharmacy services).

MEDICATION USE GUIDELINES› It should detail guidelines which are approved or

endorsed by the P&T committee.

› Such guidelines may include pre-printed orders and clinical pathways that have been developed.

SOME EXAMPLES: Antibiotic use guidelines Antibiotic use in surgical prophylaxis Weight-based heparin orders ICU sedation guidelines

SPECIAL INFORMATION› The information is health-system specific

› Should be tailored to the needs of the professional and medical staff

SOME EXAMPLES OF TOPICS TO INCLUDE:

o Nutritional products approved for use

o Equivalent dosage tablets (e.g., pain medications)

o Antidote list

o Serum drug levels

o Antibiograms

PUBLISHING THE FORMULARY

› Must be published regularly

› Medication list should be readily available to all personnel involved

› Electronic versions may be preferable

› Copies should be made available where medications are prescribed, dispensed, and administered

› Printed formularies are often revised and printed annually

› A method for updating the formulary between editions should be established

“No Medicine cures

what Happiness cannot.”

-Gabriel Garcia Marquez

THANK YOU!!

MEDICATION-MANAGEMENT.pptx

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