Key Issues to Address
Literature

Prescribing Information

An excellent place to begin. It contains the most relevant drug information related to the drug.

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Diagnostics

Companion Diagnostic Tests

Pharmacogenetic and genomic testing can dictate the selection of the most effective and targeted drug therapy. Including this in your evaluation is key to understanding how a medication will be used.

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Safety

Safety

Safety issues for a medication such as adverse effects and confusing drug names, should be identified and plans for mitigating any risks should be outlined.

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Economics

Financial Considerations

Identify and describe any issues related to the finances of a medication, such as cost-effectiveness, budget impact, reimbursement, and drug waste among others.

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Patient Assistance

Patient Assistance Programs

Identify patient assistance programs that are available to assist patients and health systems offset the high cost of medications.

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Electronic Records

EMR and EHR Considerations

With each new medication added to the formulary, these electronic systems also need to be updated. Having an organized approach to updating these systems is critical to ensuring the safe use of all medications.

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Purchasing

Purchasing and Technology Checklist Considerationsn

Many factors related to obtaining a medication need to be considered. These checklists are a good place to start.

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Presentation

P&T Committee Formulary Recommendation

A pharmacist's preparation is the most important component when presenting a drug monograph. This section provides tips on how pharmacists can prepare to present a drug monograph to the P&T committee.

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Key Issues to Address

This section outlines other key elements for consideration when researching a formulary request and evaluating a product for formulary inclusion.

Literature Appraisal

The manufacturer's prescribing information summarizes the clinical trial results that the FDA required the manufacturer to conduct to demonstrate safety and efficacy. These studies are often referred to the pivotal studies that led to the drug's approval and should serve as the backbone for the review. These pivotal studies should be accessed and reviewed in full through an indexing/abstract service, when available. Barriers to a robust literature appraisal include studies in which are not be published in full and may be available as “data on file” with the manufacturer or studies that include pooled data across multiple studies which can make tracking patients difficult as a result of drop-outs, loss to follow-up, or exclusions for example.

Over the past 10 years, medications are being approved by the FDA with fewer published studies than in previous years. The traditional paradigm for FDA-approved medications involved conducting a Phase I trial to establish a dose, a Phase II trial to determine preliminary evidence of efficacy and a Phase III trial to compare the new medication to the standard therapy. This model led to delays in getting critically important medications on the market for patients who needed them. In response, regulators and legislators created several programs to expedite the approval of important medications. The programs include the Orphan Drug Act, the Fast Track designation, Accelerated Approval, Priority Review and Breakthrough Therapy designation. As a result, It is not unreasonable to have a medication approved by the FDA with only a Phase Ib and a Phase II clinical trial.

"Evidence tables present study details in a consistent and organized format to allow for for objective, between-study comparisons."

Evidence tables may be especially useful if you have studies that have used varying medication doses and study methodology. Create your evidence table comparing each study's methodology, but also consider both primary and secondary outcomes for the condition the drug is being used to treat. For each of the outcomes stated in the methodology, the same primary and secondary outcomes should be included in the results. Include study limitations within the evidence table as this can help identify caveats to the study findings, (e.g., higher than normal patient drop out rate, recall bias on the part of participants, non-statistically significant findings, non-clinically significant findings, carry-over of effects in a cross-over trial, etc.).

A common misconception that is made when reviewing published studies that demonstrate a treatment effect with a new medication is that the sample size was too small. If the study was able to detect a statistically significant difference in the treatment effect, than the study had an adequate sample size. Although the seemingly small study found a treatment effect, this doesn't mean it was underpowered, but rather the study was small and could not be generalized to other populations i.e., lacking external validity. When summarizing limitations of studies, be sure to provide the reason for the limitation observed.

Many studies that are published are funded by the manufacturer of the medication in question and should indicate this funding source. This is often highlighted as a source of potential bias. However, most published studies today are either funded by the pharmaceutical industry, a government organization (National Institutes of Health) or by a private funding source. Pharmaceutical industry plays an important role in researching and bringing medications to the market and shouldn't automatically be considered biased or flawed research. As with any study, a careful review of the study design, the role of each investigator played in the design and execution of the study as well as financial disclosures and conflicts of interest should be reported which can help to mitigate any perceived bias.

Companion Diagnostic Tests

The field of personalized medicine is growing allowing for a greater role of pharmacogenetic/genomic testing. Importantly, pharmacogenetic/genomic testing can dictate the selection of the most effective and targeted drug therapy. Evaluating the test and it's specificity and sensitivity are essential to determining the appropriate patient to receive the medication. The evaluation of the diagnostic test should include an estimate of the number of patients that may inappropriately receive the therapy, those that many experience a negative outcome, or require additional testing.

Oncology therapies are commonly being approved by the FDA with a companion diagnostic test, and these types of tests should be reviewed and assessed within the drug monograph. Additionally when utilizing new equipment like diagnostic testing that provides new information, its important to understand the relevance of the new information and if it is based on clinically relevant and meaningful data so that it can be trusted to modify medication management decisions.

Once a medication with a companion diagnostic test is added to the formulary, the laboratory EHR system display of the diagnostic test result is critical to drive successful utilization of the medication. The diagnostic test result should be displayed in a meaningful way for the clinician to make just-in-time clinical decisions. This can also apply to antimicrobial therapy and having access to culture and susceptibility data readily available. One way to achieve this is to link the diagnostic test results and utilization criteria to the medication at the time of ordering as this can direct prescribers to use the medication more appropriately and assist with pharmacist review and approval. If the medication requires routine monitoring, tools can be built into the pharmacy EHR to support and manage the medication regimen adjustments and document changes.

A useful resource that contains guidelines on genetic testing is called the Clinical Pharmacogenetics Implementation Consortium (CPIC). The use of high-throughput genetic testing in clinical practice is an emerging area of practice and one that will likely become more frequently used. The guidelines contained within the consortium assist clinicians in determining how existing genetic test results can be used to support therapy decisions. A key assumption that the CPIC Guidelines address is that clinicians will have access to genetic test results well before therapy is considered. All recommendations are evidence-based and include the standard system for grading levels of evidence linking genotypes to phenotypes. Register with CPIC to receive updates on changes to the guidelines.

Required Monitoring Parameters

Some medications may require laboratory monitoring before, during and continuously once the medication is started. The laboratory monitoring timing and frequency should be indicated within the drug monograph and the additional costs for these laboratory tests should be included in the cost analysis. Examples of this include the time to draw the laboratory test (the technician's time), the cost associated with processing and interpreting the result, etc.). Importantly, the EMR should be designed in such a way that the laboratory results are connected to the therapy so that the monitoring parameters are interoperable within the EMR.

Safety

  • Adverse Effects

    The prescribing information contains information on the safety of a medication that is based on animal (e.g. carcinogenic, mutagenic and reproductive effects), preclinical and clinical trial data. The data reported are collected under a controlled environment based on both patient reports and investigator observed adverse effects. The experiences reported in the adverse effects section of the prescribing information should be included in the drug monograph; however, they are reported under a controlled environment where patients tend to be healthier than the general population and may be taking fewer medications than those who may use the medication once it is widely marketed. Additionally, the causality between the medication and the adverse effect observed in the clinical trial and listed in the prescribing information can not be inferred.

    Other important considerations to highlight include the frequency of an adverse effect as compared to placebo versus when compared the standard therapy. Additionally, it is important to identify the adverse effects associated with the disease state (regardless of whether a therapy is administered) as this can help explain adverse effects that can occur with high frequency in both placebo and the treatment group.

  • Confusing Drug Names

    The Institute for Medication Safety (ISMP) is a great resource for information related to sound-alike, look-alike medications. These types of potential errors involving medications are called “confused drug names” by ISMP. When evaluating a drug for formulary consideration, include any ISMP warnings so that your health system can proactively evaluate and address these risks to prevent errors before a medication is added to the formulary. TALLman lettering is one strategy used to prevent sound-alike, look-alike medication errors. The specific part of the medication name is placed in all capital letters to highlight the difference between the two medications. When TALLman lettering is used, verify that all of your systems can support the TALLman lettering, e.g., EMRs that capitalize the entire medication name vs. capitalizing only a part of the medication name. Other systems should also support TALLman lettering including labeling, ADCs, robotics/carousel.

  • High-alert Medications

    High-alert medications represent another important safety issue that should be considered when preparing a drug monograph. It may take a while before a newly FDA-approved medication is added to the list of high-alert medications; however, high-alert medications may be used to treat or manage complications resulting from a consequence of the new medication (e.g. insulin, heparin, etc.).

    The Institute for Medication Safety (ISMP) defines high-alert medications as drugs that bear a heightened risk of causing significant patient harm when they are used in error. Importantly, medication errors may or may not be more common with these drugs, however the consequences of an error are clearly more devastating to patients. When evaluating a drug for formulary consideration, determine if the medication requires special safeguards to reduce the risk of errors and minimize harm. Strategies may include:

    • Standardizing the ordering, storage, preparation, and administration of these medications
    • Improving access to information about these drugs
    • Limiting access to high-alert medications
    • Using auxiliary labels and automated alerts
    • Employing redundancies
    • Documentation of patient counseling on the potential risk vs. benefit

  • Other Health System Considerations

    When preparing a drug monograph, consider whether the medication poses unique risks such as the potential to cause malignant hyperthermia, QT prolongation and whether the medication contains gluten, carbohydrates, or latex. Unique or serious risks are often addressed in the warnings and precautions sections of the package insert or in the boxed warning section (where appropriate). Each health system may have a unique approach at tracking these specific warnings; check with your institution's specific needs to ensure you are addressing these considerations appropriately.

  • Risk Evalution and Migigation Strategies

    Through the Food and Drug Administration Amendments Act of 2007, the FDA was given the authority to request a Risk Evaluation and Mitigation Strategies (REMS) from manufacturers. REMS programs are established for medications to ensure that the benefits of the medication outweigh the risks. Not all medications are required to have a REMS; however, REMS may be a part of a new drug approval or for an approved medication when new safety information arises.

    REMS provides a way to manage a known or potentially serious risk associated with a medicine and helps to enable patients to have continued access to such medicines by managing their safe use. There are three main components of REMS, 1) communication with patients, 2) communicating to health care providers, pharmacists and healthcare settings, and 3) may include required activities or clinical interventions. Examples of these required activities or clinical interventions may include a requirement that prescribers and dispensers become certified and agree to carry out a set of activities to minimize the risk of the drug. Other activities include the requirement for prescribers, dispensers, or patients to document a “safe use condition” like a lab test, before a drug can be dispensed. Some REMS require the patient to take action for them to remain on treatment. Each medication may have unique REMS requirements and occasionally, all of these activities may be required for very high-risk medications.

    Check the prescribing information or the REMS site to determine whether the medication you are reviewing, requires a REMS, and be sure to include the essential components of the REMS within the drug monograph.

  • National Institute for Occupational Safety and Health

    The National Institute for Occupational Safety and Health (NIOSH) of the Centers for Disease Control and Prevention prepare the list of antineoplastic and other hazardous drugs used in healthcare settings. The NIOSH list summarizes over 100 medications that may pose a health risk for healthcare workers who are potentially exposed to hazardous drugs used in the workplace, including those used for cancer chemotherapy, antiviral drugs, hormones, and some bioengineered drugs. This list is updated once every 1-2 years unless there are urgent updates in which case the list would be updated sooner.

    Medications are classified into three general categories: 1) antineoplastic, 2) non-antineoplastic hazardous drugs and 3) non-antineoplastic drugs that primarily have adverse reproductive effects.

    • Antineoplastic drugs: These primarily chemotherapy drugs meet one or more of the NIOSH criteria for a hazardous drug. In addition to many of these drugs being cytotoxic (e.g., toxic to living cells), the majority are hazardous to males or females who are actively trying to conceive, women who are pregnant or may become pregnant, and women who are breastfeeding, NIOSH warns.
    • Non-antineoplastic hazardous drugs: These drugs meet one or more of the NIOSH criteria for a hazardous drug, including those with the manufacturer's safe-handling guidance. Some of these medications may pose reproductive risks similar to those described for antineoplastic drugs. Note that some of these medications may also pose a reproductive risk for susceptible populations.
    • Non-antineoplastic drugs that primarily have adverse reproductive effects: Drugs that primarily pose a reproductive risk to men and women who are actively trying to conceive and women who are pregnant or breastfeeding, because some of these drugs may be present in breast milk.

  • Special Populations

    The FDA's prescription labeling recommendations require that information for use by special populations, be included in the prescribing information. The labeling must include a concise summary of any clinically important differences in response or recommendations for the use of the drug in specific populations (e.g., differences between adult and pediatric responses, need for specific monitoring in patients with hepatic impairment, and special considerations during pregnancy, labor and delivery, nursing mothers, pediatric use and geriatric use). These sections are found in the prescribing information and are important to include in the drug monograph for health systems that treat patients that belong to these special populations.

    In some instances, the prescribing information may state that the medication in question has not been studied in children or in older adults. Under these circumstances, the primary literature should be reviewed to determine whether studies exist in these patient populations despite not being in the prescribing information. The information provided in the studies can help inform off-label use of a medication.

  • Storage and Handling

    Any special storage and handling information should be included in the drug monograph as this can help determine where the medications may be stored (e.g., freezer, refrigerator, original container, ADC, etc.) and operational considerations including the time required to remove the medication from the freezer or refrigerator in advance of administering the medication. Importantly, some oral medications require that they are kept in their original packaging.

Financial Considerations

The pharmacy billing process is complex with varying state laws and regulations.

  • Confirm the correct J Codes for medication and indication.
  • Check to see if a New Technology Add-On Payment (NTAP) is available for the medication.

340B Drug Discount Program

The 340B Drug Discount Program is a federal government program that requires drug manufacturers to provide outpatient drugs to eligible health care organizations and covered entities at significantly reduced prices. Organizations that are 340B Drug Discount Program eligible should include the discounted pricing in all financial outpatient medication calculations.

Pharmaceconomics

Due to the increasing healthcare costs in the US and corresponding medication costs, health systems have begun incorporating health economics into formulary decisions. The application of pharmacoeconomic modeling has helped to inform health systems on the value of a newly approved medication and its potential financial impact on the health system. There are many types of pharmacoeconomic analyses available that involve complex modeling. Below are three commonly used models that are used in making formulary decisions.

  • Cost-Effectiveness

    Cost-effectiveness models attempt to assess the value of the new therapy as compared to the existing treatment options (both medications and other interventions like surgery or imaging). There are many different types of cost-effectiveness models depending on the perspective in question; the value of the therapy to the patient, the insurer, the health-system, the pharmacy department for example.

  • Budget Impact

    Budget impact analyses attempt to determine the financial impact of the new therapy on the health system. This can help health systems predict downstream expenses or cost-savings after adopting the new therapy. Importantly, for this model projected new indications should be considered and included. This model does not take into account clinical outcomes or patient outcomes. Budget impact analyses can be conducted from different perspectives (e.g., hospital, patient or government sponsored plan). Please note for organizations that participate in the 340B Program, that it is important to project annual outpatient and inpatient utilization to estimate yearly financial impact.

  • Financial Impact

    The financial model is one of the most commonly used models as it estimates the cost of the new therapy on the pharmaceutical budget often through direct acquisition cost excluding outcome data or any other costs. Several federal programs are available that provide reimbursement for current treatments based on cost evaluations. The programs include the 340B, Alternative Payments Models (such as the The Medicare Access and CHIP Reauthorization Act of 2015 (MACRA) and the Merit Based Incentive Payments System (MIPS)) as well as the Oncology Care Model.

  • Comparative Effectiveness Research

    Comparative effectiveness research (CER) to help identify effective therapies for more informed medical decision making. Comparative evaluation of new therapies, either by direct or indirect comparisons provides a means to integrate current data and evaluate outcomes based on real-world data. The comparison or comparisons may involve medical or non-medical preventive strategies, diagnostic testing (single tests or several in sequence or combination) and different treatments, including medications, devices, surgeries or rehabilitative techniques.

Health-Related Quality of Life (HRQoL) measures are also called Patient Reported Outcomes (PROs) and are designed to consider the patient's perspective related to the therapy. The measures included can vary but generally attempt to quantify the patient's health status, attitude, values and general well-being. When HRQOL/PROs are available, these measures should be included in the drug monograph.

"Health-Related Quality of Life measures is of interest because of the challenges in assessing value of high cost, specialized medication therapy."

Reimbursement

One of the challenges formulary managers face is assessing third-party payer reimbursements (through commercial health plans, federal programs like Medicare or state Medicaid programs) to hospitals, health systems, and other healthcare organizations. For existing formulary medications, evaluating the institution's reimbursement for a given therapy can be delayed (e.g., a patient receiving six cycles of chemotherapy where only one cycle has been billed and paid for by the health insurance). Other challenges include payments to institutions that are bundled for a given diagnosis and do not distinguish reimbursement for a specific drug therapy. A common challenge for health systems is when specialty injectables are required during an inpatient admission where these specialty injectables are not reimbursed for inpatients. Inpatient reimbursements are bundled based on the patients diagnoses (diagnosis-related group coding) and treatments are often not itemized making reimbursement difficult to assess at the medication level. Each institution may have a unique process for accessing this type of information so check with your finance department to determine reimbursement for existing therapies within your health system.

Predicting reimbursement for a new therapy can be challenging. Typically, when Medicare establishes reimbursement schema, many commercial plans tend to follow suit. When evaluating a new therapy, determine your organization's payer mix and contact each group (e.g., commercial health plans, federal and state government-sponsored plans, etc.), to determine whether they have established coverage criteria or special requirements for use.

Drug Waste

The JW modifier is a Healthcare Common Procedure Coding System (HCPCS) Level II modifier used on a Medicare Part B drug claim to report the amount of drug or biological (hereafter referred to as drug) that is discarded and eligible for payment under the discarded drug policy. The modifier shall only be used for drugs in single dose or single use packaging. Specifically, CMS will reimburse discarded drugs or biologicals up to the dosage amount indicated on the vial or package label if:

  • The hospital makes an effort to schedule patients to use drugs or biologicals in an efficient yet, clinically appropriate manner;
  • The drug or biological is a single‐use vial or single‐use package;
  • The amount billed to Medicare as discarded drug is not administered to another patient; and
  • The drug or biological is initially administered to the patient to appropriately address the patient's condition and any unused portion is discarded.

Billing for waste based on concentration and dose should be addressed in the monograph to address billable units.

Patient Assistance Programs

When preparing a drug monograph, it is helpful to include whether there are patient assistance programs available to assist patients and health systems offset the high cost of medications.

Many patients are unable to afford their medications even if they have health insurance that provides coverage through a prescription drug plan. Patient Assistance Programs can help both patients and health systems with high-cost medications. The requirements and support offered by these programs can vary significantly depending on the disease that the medication is used to treat (e.g., oncology, neurology, gastrointestinal disease, rare diseases) and the source of the assistance (pharmaceutical manufacturer, private foundation, non-profit group, consumer advocacy group, state government program). An application process is typically involved, and this should be accomplished as soon as possible to allow time for application processing and approval. If your organization participates in these programs, it's important to determine which programs are available and how much assistance you can obtain for the patient or the health system.

Visit drug manufacturer websites to determine if a manufacturer-sponsored patient assistance program exists."

Contact the manufacturer directly to inquire about other forms of assistance from the groups mentioned previously as the manufacturer can direct you to the right source for more information. When communicating with the manufacturer, be sure to include details regarding the patient's eligibility requirements, if assistance is available through an individual application or a bulk replacement program, if samples are available, whether the product is sent directly to the patient or the institution, if the product will be labeled specifically for the patient or if it will serve as a replacement of what was used, and whether the product requires IV sterile compounding, etc.

Helpful resources for patient assistance programs include NeedyMeds and RxAssist. These sites contain comprehensive information on a variety of patient assistance programs and include an interactive tool that allows the user to calculate each patient's eligibility for financial support, e.g., federal poverty level income calculator by state.

Another helpful program that some healthy systems participate in is called the bulk replacement drug program. The bulk replacement drug program is a form of a pharmaceutical donation. The health system provides the prescription medication to the patient for free and the manufacturer replaces the product back to the health system at no cost. If your health system outsources or completes patient assistance program drug recovery after a medication is administered in the inpatient or outpatient areas, evaluate if a program is available and inform the team if so.

Electronic Medical Record (EMR) and Electronic Health Record (EHR) Considerations

Health Systems across the country are increasingly using EMR/EHR systems to support the care they provide to patients. Within these systems, Computerized Physician Order Entry (CPOE) and Barcode Medication Administration (BCMA) may also be included. With each new medication added to the formulary, these electronic systems also need to be updated. Having an organized approach to updating these systems is critical to ensuring the safe use of all medications. Each institution should identify all of the systems that will need to updated for each new medication considered. The following are some sample considerations that would be important to include in a supplemental appendix to the drug monograph that can serve as a helpful checklist.

  • Ordering template - order sets, order panels - change request is made to initiate or update
  • Clinical decision support rules - dose range checking, drug-drug interactions (alerts), duplication therapy warnings (alert fatigue), provider/pharmacist/other
  • E-prescribing - depending on the platform that your organization is using, need to have the most updated content to avoid mismatch

Purchasing Checklist Considerations

Product Generic Name
Product Brand Name
Product type (tab, capsule, IV, IV bag, etc.)
Product dose

  • What is lowest cost medication option?
  • What dosage forms are available?
  • Is medication on contract?
  • If oral medication, is it unit dosed?
  • If IV medication, is it available in a premixed IV solution?
  • If IV medication, does it require compounding?
  • Does the product come with a diluent or is a specific diluent required?
  • What is the price difference between premixed IV solution and compounded product?
  • Is the product refrigerated?
  • Is the product frozen?
  • Does the product have any special storage conditions?
  • Does the pharmacy wholesaler stock the medication?
  • Does the pharmacy wholesaler currently have adequate stock on hand?
  • Provide projected annual volume to pharmacy wholesaler to adequately stock at the local warehouse?
  • Does the medication come from a specialty pharmacy distributor?
    • Do you have an account?
    • Set up account?
    • If 340B, set up 340B, WAC, and GPO accounts?
  • Is medication only available directly from distributor
    • Do you have an account
    • Set up account?
    • If 340B, set up 340B, WAC, and GPO accounts?
  • Does Drug Supply Chain Security Act (DSCSA) system include the manufacturer and product?
  • Identify storage location either in carrousel, robotics, or shelves
    • Add to automation formulary?
    • Add appropriate par levels for inventory management?
    • Manage and label locations according to ISMP recommendations?
    • Add a barcode to the system?
  • Reduce inventory of medication being replaced prior to conversion to new medication if possible
  • Order in new product and communicate to all that medication is available operationally when ready

Technology Checklist Considerations

Identify the systems that the institution should update as being a formulary item including purchasing/distributor source, automated dispensing cabinet, EMR, CPOE, BCMA, etc.

Technology/Automation Considerations
  • Smart Pumps (standard concentrations, updates, ways to notify others of updates)
  • Carousels/Robotics
  • Automated Dispensing Cabinets (ADCs) - restock on bar code scan (new internal NDC number on the vial vs. one on the box)
  • IV Workflow Software
  • Prepacking systems and compounding documentation software
  • Labeling (unclear labeling that can result in error, extensive label comments that are truncated, mismatch between IV workflow system and EMR)
  • Other stand-alone systems requiring drug formularies

Pharmacy & Therapeutics Committee Meetings Formulary Recommendation

Following the review of the medication, a clear and focused recommendation should be made regarding the medication that is before the P&T committee.

Each health system may have unique needs that depend on the size of the organization and the acuity of the patients. Other areas of service that should be considered when formulating a recommendation include the inpatient or outpatient setting, procedural areas, acute care/urgent care centers, or other similar areas of service. Importantly, a health system's reimbursement may vary significantly based on the area of service that the medication is being used and administered and this should be considered when formulating a recommendation for use.

Restricting a medication to a specific service or group of specialty providers serves to ensure safe use particularly for medications that require special training to administer, a heightened awareness of complications and access to emergency procedures, equipment or medication antidotes or reversal agents.

The complexity of medications being FDA-approved is creating challenges for health systems. These challenges are centered around the approval of high-cost, highly specialized medications that may have unique procurement and administration issues. To address these challenges, the framework for designating a medication as “formulary” or “non-formulary” is inadequate to address these challenges and therefore should be individualized. Several approaches may be used and the following formulary categories may be considered:

  • Formulary, stocked
  • Formulary, not consistently stocked
  • Formulary, restricted
  • Formulary, requirement for confirmation of benefits or coverage prior to use
  • Formulary, for outpatient/clinic use only
  • Non-formulary, stocked
  • Non-formulary, not stocked

Presentation Considerations

Pharmacists are integral in preparing drug monographs, reviewing and appraising the literature and in presenting the data to support or refute a drug's use within the health system. As a result, a pharmacist's preparation is the most important component when presenting a drug monograph. This section will provide suggestions on how pharmacists can prepare for a presentation of a drug monograph before a P&T committee.

Pharmacists should review the presentation ahead of time to eliminate any typographical errors and rehearse both timing and the proper pronunciation of medication names. These suggestions seem intuitive but when they are not observed, it can reflect poorly on the presenter making them appear, uninformed, unprepared and careless.

Ideally, the generic name should be used to refer to the medication unless the name is very complex, long or challenging to repeat. In which case, both names should be stated the first time, and the audience should be informed that from this point forward, the medication will be referred to by its brand name for simplicity.

Pharmacists are medication experts and are uniquely positioned to be the most knowledgeable about medications and available evidence.

During the presentation, the pharmacist should demonstrate confidence in the information they are sharing through body language, pace, tone, volume, eye contact and deference to the expertise of other healthcare professionals.

Prior to presentation of the drug monograph, elicit input from other services or providers including pharmacy purchasing, medicine, nursing, respiratory therapy and other health professions who will be involved with the ordering, use or administration of the medication. This can preempt any issues related to operations, education, training, ordering or monitoring issues once the medication is approved for use.

Managing Challenges and Conflicts

Pharmacy & Therapeutics committees attempt to approve new and important therapies that will improve patient care and have a strong evidence-base. Usually these two principles align well and the medication is added to the medication formulary. Occasionally, medications with inconsistent or equivocal evidence-base are requested for formulary addition. This can create a challenge for the pharmacist to manage.

If the pharmacist is recommending against adding a medication to the formulary, the pharmacist should share this recommendation with the requesting provider in advance of the meeting. This is to encourage a constructive and peer-to-peer professional conversation and avoid an adversarial confrontation during the Pharmacy & Therapeutics committee meeting. Another strategy that the pharmacist may use, is to alert or prepare P&T committee members regarding the recommendation of not adding the medication in advance of the meeting. The pharmacist can thereby identify physician allies and help create a strategy whereby a physician peer can reach out to the requesting provider.

A decision to not add a medication to formulary should include a discussion about the desire to allow access to important therapies, but that this should be balanced by medications that have a solid evidence-base and that are considered to be safe and effective. Areas of compromise may be identified and can include a variety of options. For example, granting the medication temporary formulary status to assess the medication's value may be considered with the understanding the medication may be removed from the formulary if the data show that it was ineffective or led to complications or adverse effects. Another area of compromise may be in restricting the use of the medication to a specific service or specialty as compared to allowing health system-wide access. This strategy may help to focus use on one patient population that is well defined and can allow for enhanced monitoring.

Occasionally, when a difference of opinion arises regarding a medication, misinformation may be inadvertently introduced in an effort to elicit support for a specific position on a formulary recommendation. Specifically, personal experience or anecdote is a common challenge that can emerge within P&T committee discussions. Clinicians may offer their experiences highlighting unique or memorable medication-related patient experiences in an effort to change the outcome of a formulary recommendation. This approach is not desirable because it does not account for a population perspective and generalizes the experience of one patient to the entire population. It is important to remind clinicians when the evidence-base does or does not support the anecdote in question.

Evidence-based medicine is designed to minimize personal experience and anecdote from formulary decisions.

Importantly, P&T committees require that a medication will only be presented for formulary consideration if the requesting provider attends the meeting. This is to ensure that the medication is given full consideration and that the provider can respond to any questions that arise. The requesting provider should also be asked to leave the room during the P&T committee deliberation and final vote. This allows for committee members to have an open and honest discussion without influence.

At any time during the P&T medication formulary process, requesting providers, pharmacists or any other health care professionals with conflict of interest surrounding the medication in question or the medication/device manufacturer should recuse themselves from the discussion and vote. Importantly, and financial disclosures must be outlined ahead of time and the institution's policy for addressing financial disclosures and conflict of interest should be followed.

Medical Executive Committee

Each health system's organization structure has a governance committee for all medical staff. This committee is often called a Medical Executive Committee or Executive Medical Board. This committee receives input from the medical staff of the health system on a variety of issues. In addition, the Committee makes important leadership decisions, established medical staff policies, oversees quality control and quality improvement initiatives. This Committee also votes to adopt the actions approved by the Pharmacy & Therapeutics committee.