The document discusses medication management and formulary systems. It defines key terms like drug monographs and formularies. It describes the roles and responsibilities of pharmacy and therapeutics committees in establishing policies on medication use, selecting drugs for the formulary, and monitoring outcomes. The committees are multidisciplinary and work to select medications, establish guidelines, and evaluate medication use and safety within their healthcare organizations.
The document discusses medication management and formulary systems. It defines key terms like drug monographs and formularies. It describes the roles and responsibilities of pharmacy and therapeutics committees in establishing policies on medication use, selecting drugs for the formulary, and monitoring outcomes. The committees are multidisciplinary and work to select medications, establish guidelines, and evaluate medication use and safety within their healthcare organizations.
The document discusses medication management and formulary systems. It defines key terms like drug monographs and formularies. It describes the roles and responsibilities of pharmacy and therapeutics committees in establishing policies on medication use, selecting drugs for the formulary, and monitoring outcomes. The committees are multidisciplinary and work to select medications, establish guidelines, and evaluate medication use and safety within their healthcare organizations.
4: Medication Management • Select medications for inclusion by considering
clinical, quality of life, safety & Key Terms & Definitions pharmacoeconomic outcomes • Drug monograph – written, unbiased • Evaluates med use outcomes evaluation of a specific medication; drug name, • Monitors adverse drug reactions therapeutic class, pharmacology, indications, • Develops policies & procedures for handling clinical trials, ADE, drug interactions medications • Educate health professionals The Formulary System Formulary System Maintenance – ongoing process whereby a HCO establishes policies on • Review medication list & guidelines on a regular the use of drug products & therapies basis • Drug Formulary – continually updated list of Medication Selection and Review medications & related info, representing the • Established methods for medication selection & clinical judgment of RPh, physicians & other review experts in treatment of disease & promotion of • Med.selection criteria: med efficacy, safety & cost health • Barriers to optimal formulary decisions • List of medications routinely stocked o Physician experience w/ drug & • developed in the 1950s as a management tool ; preference discourage the use of marginally effective drugs o Detailing by pharmaceutical company & treatments representatives • Element of a system that includes med. Use o Unpublished / anecdotal studies policies, PT&C, med use evaluation, & formulary Medication Use Evaluation ( MUE ) management • Method for evaluating & improving med-use • Advantage: provides a systematic method to process w/ the goal of optimal patient outcomes review scientific evidence on clinical • Foundation of med-use process effectiveness in drug selection decision o Establish a specific criteria for use • Disadvantage: overly restrictive formulary, o Review for compliance ; Routine review limited access to medications of data • Key to process – timely data to review, action Pharmacy & Therapeutics Committee plan development , follow up Organization Medication Safety Evaluation • Committee is a policy recommending body to the • Evaluated through adverse drug reaction reports medical staff & medication error reports • Medical executive committee – grp of the Drug Therapy Guidelines hospital medical staff in charge of institutional • Listing of the indications, dosage regimens, governance & performance ; w/ primary duration of therapy, mode of administration, authority for activities related to self governance monitoring parameters & special precautions & performance improvement • Developed w/ the oversight of practitioners w/ • Health-system board - non-medical staff expertise in the management of disease advisory committee of hospital members & o Use of pre-printed physician order sheet community members that governs the affairs of Policy and Procedure Development hospital • Medication administration process • Subcommittees / task forces – facilitate meeting • Medications administered in specific locations efficiency Education o Medication safety – review of adverse • Newsletter that includes clinical info on drugs drug events & med errors • Presentation at meetings, health-system website o Medication use review – performance- improvement method that focuses on Regulatory & Accrediting Bodies evaluating & improving med-use • RB: State Dept of Health , Board of Pharmacy processes for optimal pt outcomes • AB: TJC , AOA, Commission on Accreditation of o Drug review panels – review drug in an Rehabilitation Facilities ( CARF ) area of specialty ( cardiology ) Pharmacist Role Committee Membership • Establish P&T committee meeting • RPh, nurses, physicians, administrators, risk / • Analyze & disseminate scientific, clinical quality improvement managers information • Medication management is a multidisciplinary • Conduct drug use evaluation process • Record & archive P&TC committee actions • Follow-up w/ research Responsibilities • Communicate PTC decisions to other health care • Establish & maintain the formulary system professionals
Formulary Management • Dosage form and cost – table listing comparable • Open Formularies – generally large, no limitation agents may be useful in formulary addition to access to a medication • Summary • Recommendation – formulary addition, restriction, • Closed formularies – limited list of medications deletion to specific physicians, patient care areas, disease • References –peer-reviewed primary literature states via formulary restrictions
• Formulary Restrictions –act of limiting the use fo Therapeutic Class review specific formulary medications to specific • Should not be too broad or all inclusive physicians based on areas of expertise • New medical info, adverse event profiles, • Institute of Medicine ( IOM ) evaluated the purchase or use data Veterans Administration ( VA ) National • Objective; have the optimal agents w/in each Formulary impact on health care costs in six consideration closed or preferred class of drugs
• FDS defines the equivalence of indiv chemical Formulary Changes entities or generic equivalents • Process to continually update the formulary o Approved Drug Products w/ must be established Therapeutic Equivalence – Orange Book • Submission of request for making additions & • Therapeutic Equivalents deletions ( agent to be added/deleted, rationale o Drug products w/ diff chemical for request, alternative agents ) structure but same pharmacologic /
therapeutic class and effects ( ex. 1st gen. Nonformulary Drug Review cephalosporin , histamine-2 blockers ) • Nonformulary agent – medication not part of • Therapeutic Interchange drug formulary ; not considered but P&TC o Authorized exchange of therapeutic choosing to add it alternatives in accordance w/ • Automating medication prescribing process previously approved guidelines ; must o Computerized prescriber order entry include dosage strength, frequency, & o Order Entry Rules – logic established route of administration w/in the hospital info system order • Guidelines for generic substitution entry module to notify prescribers of o RPh is responsible for selecting generic adverse effects ; include weight based drugs ; P&TC determines therapeutic dosing, laboratory tests, allergy checks equivalents o Pop-ups – info that appears on a o Prescribers may specify a specific brand computer monitor when a specific if clinically justified actions are taken ; may contain clinical • Formulary maintenance – ongoing process of info about med use, drug interactions assuring relative safety & efficacy of agents
available for use Drug Use Evaluation ( DUE ) o New product evaluation • Systematic process used to assess the o Therapeutic class review – evaluation of appropriateness of drug therapy by engaging in a group of medications w/ an the evaluation of data on drug use established therapeutic class ; indication • Medication Use Evaluation ( MUE ) – for use, dynamics, ADE, drug encompasses the goals & objectives of DUE in its interactions broadest application o Formulary changes • first established in 1980s o Nonformulary drug use review • provide an ongoing, structured, organized
approach to ensure that drugs are used New Product Evaluation ( standard elements ) • Generic name – name of all chemical entities appropriately • Trade name • Outcome assessment – systematic process of • Therapeutic / Pharmacologic Class evaluating the appropriateness, safety, & efficacy • Pharmacology – mechanism of action & of a medication ; review of pt medical records pharmacologic effects • Multiple performance improvement models • Pharmacokinetics – how drug is handled by the body, o FOCUS-PDCA ( or PDSA ) onset of effect, serum half-life, metabolic § Find process to improve considerations, route of excretion § Organize a team that knows • Indications for use § Clarify current knowledge • Clinical studies – clinical study data supporting § Understand causes of process indications for use ( statistical analysis, outcomes, info variation on patient info ) § Select process improvement • Adverse effects/ warnings – methods to reduce , risk § Plan ; Do ; Check ( or study ) ; Act & benefit of drug therapy, precautions in pregnancy • Drug interactions – drug-drug, drug-food • Dosage range – dosage range for diff routes, age, hepatic function • Medication use criteria • Floor Stock – criteria for selecting agents for floor o Diagnosis-related DUE –criteria identify stock indications for w/c select drugs may be • Definition of order interpretation – meaning of appropriate for a given disease specific types of orders ( sliding scale orders, ranger orders, needed, tapering, titrating orders) o Prescriber-related DUE – identify • Medication Administration times – specific time & specific physicians whom the P&TC has rules for interpretation determined may use certain drugs • Adverse Drug Reactions o Drug-specific DUE – focus on specific • Medication errors aspects of select drug such as dose or frequency Published Formulary • Data should be collected during the patient visit ( • Should provide info on the medications concurrent ) rather than retrospectively ( chart approved for use, basic therapeutic information review ) about each item • Technology: Personal Data Assistant ( PDA ) • Task force should develop an action plan & Medication List criteria • Includes entries for each medication and indexes • Action plan: devlpt of drug use guidelines, to facilitate use preprinted orders, med order entry rules, • Generic name of Primary active ingredient formulary changes • Trade or Synonym name that is commonly used
• Dosage form, strength, & size stocked Medication Use Policies • Active ingredients ( formulation ) • Formulary management ; P&T committee ; • DEA schedule medication prescribing, dispensing, administration • Special precautions • Pediatric / adult dosage ranges Formulary Management • Cost information • Should include information on who use a specific • Index arranged alphabetically or generically by agent ; how a drug is added / deleted, stocked therapeutic class • Formulary Restriction policy –define how items are selected for formulary restriction, rationale Medication Use Policy & Procedures for selecting prescribers, method of managing • Info on prescribing, dispensing, administration process • Formulary policy – describe the method for drug Medication Use Guidelines addition & deletion ( chemical entity , dosage • Detailed guidelines for medication use forms, strengths ) • Antibiotic use guidelines ; antibiotic use in surgical prophylaxis Pharmacy and Therapeutics Committee • Weight-based heparin orders • Should address the committee membership, • ICU sedation guidelines ; alcohol detox orders operation and responsibilities • potassium replacement order • thrombolytic therapy guidelines for stroke Medication Prescribing, Dispensing, & Administration Special information • Writing Medication Orders – defines practitioners that • Health-system specific may write Rx ; format of Rx • Tailored to the needs of the professional & • Verbal Orders – defines who may accept a verbal medical staff based on the services order & the transcription process ; address the • Nutritional products approved ; equivalent reading back of the order dosage tab ; parenteral nutrition formula ; • Stop Orders – defines the orders that are pediatric dosage ; antidote list ; serum drug level automatically terminated, method of reinstatement ; for medications that require additional evaluation ; antibiograms ; common equations ; advanced • Investigational Drug Orders –defines how cardiac life support investigational drugs are managed in the health care system; include review process & method for prescribing, dispensing • Controlled Substances – defines the flow of controlled substances ; approved prescribers, order process, distribution & tracking • Generic & therapeutic Substitution – defines how a drug is selected for generic substitution ; describe alternative agent • Self-administration of medications – conditions & process for the adminis. of med by the pt. • Medication Samples – conditions & process for the use of med samples