Antimicrobial stewardship programs (ASPs) are often tasked with addressing a wide scope of antimicrobial misuse with limited resources. 

To focus their efforts, program administrators should target low-hanging fruit and commonly encountered conditions such as community-acquired pneumonia (CAP).

 Nationally, CAP is responsible for about 600,000 hospital admissions per year.

 If each of those admitted patients were to receive 5 to 7 days of antimicrobial therapy, that would account for a minimum of 3 million to 4.2 million days of antimicrobial therapy. At Alaska Medical Center in Anchorage, optimizing antimicrobial therapy in patients with CAP has annually accounted for 19% to 21% of ASP interventions. Given the frequency of CAP-related admissions and the overall antimicrobial consumption in these patients, special attention should be paid to optimizing antimicrobial therapy in this population.

Effective antimicrobial stewardship begins with appropriate diagnosis. CAP can be difficult to diagnose, given that presenting symptoms may lead to a wide differential, including cancer, embolism pulmonary edema, and viral infection.

 This considered, several diagnostic tools, such as respiratory pathogen panels (RPPs), have gained attention since the publication of the Infectious Diseases Society of America (IDSA) CAP guidelines in 2007.

 These RPPs, which typically use polymerase chain reaction (PCR) technology, contain primers for multiple respiratory viruses and a few atypical bacteria. The 2016 IDSA guideline regarding the implementation of an ASP specifically recommends that rapid viral testing be used for respiratory pathogens in an attempt to curb inappropriate antimicrobial prescribing (weak recommendation/low-quality evidence).

 Conversely, some institutions have found that RPPs function to increase diagnostic accuracy but have little impact on reducing antimicrobial durations.

 Onboarding of an RPP should be accompanied by provider education to specify in which clinical circumstances the test may be most useful. Special attention should also be given to rapidly addressing results and pairing RPP use with other diagnostic markers, such as procalcitonin (PCT). PCT, an amino acid precursor of calcitonin, has been shown to elevate above-normal physiologic levels in bacterial lower respiratory tract infections (LRTIs) but not in viral infections.

Levels rise within 2 to 4 hours of onset, peak between 8 and 24 hours, and have a half-life of about 24 hours.

 Use of PCT has been shown to decrease inappropriate antibiotic initiation and the duration of therapy in patients with LRTIs.

 As such, PCT is likely a reasonable target for ASPs looking to optimize both antibiotic therapy and diagnostic accuracy in CAP.

Regarding selection of appropriate drug regimens, the 2007 IDSA CAP guideline suggests either monotherapy with a respiratory fluoroquinolone or a third-generation cephalosporin in combination with a macrolide.

 The aim of both regimens is to provide coverage of both atypical and typical CAP pathogens.

 Despite the findings of one recent Dutch study in non—intensive care unit CAP, most of the primary literature suggests that empiric coverage of atypical pathogens continues to contribute to improved outcomes in hospitalized patients with CAP.

 Thus, deviation from the inpatient regimen recommended by the IDSA does not appear prudent. However, when selecting a regimen from the 2 guideline compliant options, it appears that the β-lactam—macrolide combination confers superior clinical outcomes to those of a respiratory fluoroquinolone.

 Given these data, coupled with the undesirable adverse event (AE) profile of fluoroquinolones and no need for antipseudomonal coverage in most patients with CAP, it may be prudent for ASPs to focus on using β-lactam—macrolide regimens as the first-line treatment for inpatients with CAP and reserving fluoroquinolones for those with true penicillin allergies. 

Dose optimization is another target for ASPs in patients with CAP. Azithromycin is the most common macrolide used for atypical pathogen coverage, but the IDSA guideline does not recommend a specific dosing strategy.

 Comparable areas under the curve occur with administration of the same total dose of azithromycin (1.5 g) over 3 versus 5 days.

 Thus, 3 days of azithromycin therapy is appropriate for CAP, and programs may consider recommending 500 mg of azithromycin daily for 3 days. Ceftriaxone, the third-generation cephalosporin commonly used to treat CAP, has a dose range provided by the IDSA of 1 to 2 g daily.

 Early studies assessed both doses and found equal efficacy for treatment of moderate to severe CAP. Therefore, daily doses of 1 g may be sufficient for most patients.

 Two-gram doses may be more appropriate in obese patients because of increased volume of distribution or in those with CAP who are critically ill.

Despite the positive evidence behind intravenous (IV) to per oral (PO) conversion, this intervention is not always routinely performed.

 Although the oral bioavailability of azithromycin is about 34% to 52%, the high, persistent concentrations of the drug in bronchial secretions support 1:1 IV to PO conversion.

 Given these pharmacokinetic properties, a low-hanging fruit for ASPs may be inclusion of azithromycin to automatic IV to PO interchange protocols.

A final ASP target in patients with CAP is optimization of antibiotic treatment duration. The IDSA recommends a minimum of 5 days, though 7 to 10 days is the usual

treatment duration for patients with CAP reported in literature.

 According to several reports, antibiotic duration was decreased from a median of 10 days to 7 without negatively affecting clinical outcomes, and growing evidence suggests that even shorter durations can be safe and effective.

 One of the major hurdles to shortening therapy is providing evidence to support early discontinuation. Use of patient-specific PCT trends during a course of therapy can support early discontinuation as PCT values normalize.

 As an acute phase reactant, PCT corresponds closely with the onset and resolution of bacterial infections.

 When levels are checked every 48 to 72 hours, a reduction to a value of <0.25 ng/mL, or a 80% to 90% reduction from peak values of >5 ng/mL, can serve as cutoff markers for safe antibiotic discontinuation.

 Although there are populations in which use of a PCT algorithm may be less useful, in the typical patient with an LRTI, it may lead to earlier discontinuation of antibiotics without increasing AEs.

ASP programs, both new and well established, seeking to further refine management of CAP should focus efforts on these opportunities to optimize the diagnosis, drug selection, dosing, de-escalation, and duration of therapy within their institution.

Ryan W. Stevens, PharmD, BCPS, is an infectious diseases clinical specialist at Providence Alaska Medical Center in Anchorage. Ann-Chee Cheng, PharmD, is completing a PGY1 pharmacy practice residency at Providence Alaska Medical Center.

Goff DA, Bauer KA, Reed EE, Stevenson KB, Taylor JJ, West JE. Is the “low-hanging fruit” worth picking for antimicrobial stewardship programs? 

2012;55(4):587-592. doi: 10.1093/cid/cis494.

Barlam TF, Cosgrove SE, Abbo LM, et al. Implementing an antibiotic stewardship program: guidelines by the Infectious Diseases Society of America and the Society for Healthcare Epidemiology of America. 

 2016;62(10):e51-e77. doi: 10.1093/cid/ciw118.

Lee JS, Giesler DL, Gellad WF, Fine MJ. Antibiotic therapy for adults hospitalized with community-acquired pneumonia: a systematic review. 

 2016;315(6):593-602. doi: 10.1001/jama.2016.0115.

Musher DM, Thorner AR. Community-acquired pneumonia. 

 2014;371(17):1619-1628. doi: 10.1056/NEJMra1312885.

Mandell LA, Wunderink RG, Anzueto A, et al. Infectious Diseases Society of America/American Thoracic Society consensus guidelines on the management of community-acquired pneumonia. 

 2007;44(suppl 2):S27-S72. doi: 10.1086/511159.

Oosterheert JJ, van Loon AM, Schuurman R, et al. Impact of rapid detection of viral and atypical bacterial pathogens by real-time polymerase chain reaction for patients with lower respiratory tract infection. 

 2005;41(10):1438-1444. doi: 10.1086/497134.

Semret M, Schiller I, Jardin BA, et al. Multiplex respiratory virus testing for antimicrobial stewardship: a prospective assessment of antimicrobial use and clinical outcomes among hospitalized adults. 

 2017;216(8):936-944. doi: 10.1093/infdis/jix288.

Simon L, Gauvin F, Amre DK, Saint-Louis P, Lacroix J. Serum procalcitonin and C-reactive protein levels as markers of bacterial infection: a systematic review and meta-analysis. 

Scheutz P, Christ-Crain M, Thomann R. Effect of procalcitonin-based guidelines vs standard guidelines on antibiotic use in lower respiratory tract infection: the proHOSP randomized controlled trial. 

 2009;302(10):1059-1066. doi: 10.1001/jama.2009.1297.

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Metersky ML, Ma A, Houck PM, Bratzler DW. Antibiotics for bacteremic pneumonia: improved outcomes with macrolides but not fluoroquinolones. 

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Lodise TP, Kwa A, Cosler L, Gupta R, Smith RP. Comparison of beta-lactam and macrolide combination therapy versus fluoroquinolone monotherapy in hospitalized Veterans Affairs patients with community-acquired pneumonia. 

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Ceftriaxone dose for community-acquired pneumonia (CAP). 

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Articles

Infectious Diseases Focus

Antimicrobial stewardship programs (ASPs) are often tasked with addressing a wide scope of antimicrobial misuse with limited resources.

Antimicrobial Stewardship Targets in Community-Acquired Pneumonia

Acute pain is one of the most common complaints that lead Americans to access the health care system, resulting in more than 115 million emergency department visits each year.

 Although there is no globally accepted definition for acute pain, it can be characterized by having an inciting event or stimulus, occurring suddenly, having a limited duration of less than 3 months to 6 months, and carrying the potential to develop into a pathologic condition.

 It can relate to skeletal or soft tissue damage and may be categorized as post-spontaneous or posttraumatic, with the trauma planned (surgical) or unplanned (accidental).

 Described as the body’s “awareness of noxious signaling from newly damaged tissue,” acute pain can lead to a variety of complications, including partial and total disability, reduced quality of life, and potential progression to chronic pain.

 In fact, it has been noted that poorly controlled postoperative pain is a major cause of chronic pain after surgery. Despite recent medical advances, acute pain is often undertreated, with most patients receiving inadequate pain control, leading to increases in health care costs and the length of stays in the hospital.

Pain can be characterized in a variety of ways, including duration (acute vs chronic) and location (joint related, neuropathic, and nociceptive).

 Most acute pain can be described as nociceptive, as nociceptors are involved in the perception of pain, and their sensitization is a major cause of hyperalgesia. Although the exact substances released that result in the human perception of pain are not completely known, prostaglandins play a key role by sensitizing nociceptors.

 The perception of pain is primarily regulated by the central nervous system, which integrates afferent input from peripheral nociceptors, creating the perception of pain and further amplifying the input from peripheral nociceptors.

Nociceptive pain can be further divided into 2 types: somatic and visceral. Visceral pain is a more diffuse type that is often described as gnawing and can be hard to localize.

 Nociceptive pain results from chemical, pressure, and temperature stimuli. This type of pain is also classified as originating from bones, connective tissue (somatic), internal organs (visceral), muscle, and skin. Somatic pain is much more direct and localized, occurring in the joints, skin, and subcutaneous tissue.

 This type of pain is often associated with an inflammatory process and therefore lends itself to treatment with an anti-inflammatory agent.

The immediate goals of treatment for patients suffering from acute pain include facilitating functional recovery and reducing pain to a tolerable level. Long-term goals include improving patients’ quality of life, reducing the risk of complications (eg, progression to chronic pain), and reducing overall health care—related costs.

 Multimodal treatment is crucial for optimizing pain relief. Because different modalities may be additive or synergistic, this approach can also reduce the potential for adverse effects (AEs). Analgesics, including acetaminophen and nonsteroidal anti-inflammatory drugs (NSAIDs), are most effective for treating acute pain because they target the natural inflammation that occurs with an injury.

Acetaminophen is a centrally acting agent with a variety of effects, including the decrease of prostaglandin synthesis, and is used as monotherapy for mild pain and an adjunct to therapy in moderate to severe pain. Results from studies have shown that acetaminophen provides similar analgesic control as NSAIDs for patients with mild to moderate pain.

 A recent Cochrane review noted that acetaminophen is preferred over NSAIDs as a first-line treatment because of the cardiovascular and gastrointestinal AEs of NSAIDs.

Additionally, because of acetaminophen’s lack of effect on blood pressure, it is the analgesic of choice in patients with hypertension and renal impairment.

 Although this medication can be used in a wide patient population, it should be avoided in those with alcohol problems or liver disease.

NSAIDs inhibit the cyclooxygenase enzymes decreasing prostaglandin synthesis, leadingto greater anti-inflammatory effects than acetaminophen, and are the agents of choice for acute pain because of prostaglandin-mediated inflammation. NSAIDs are preferred over acetaminophen for pain associated with dysmenorrhea and osteoarthritis.

 The results of a recent meta-analysis showed that individual NSAIDs differ in their analgesic properties from what was reported in previous studies, the results of which indicated that the individual drugs shared similar analgesic relief. Patients contending with bleeding disorders, coronary artery disease, gastroesophageal reflux disease, peptic ulcers, renal impairment, or stroke should avoid NSAIDs.

COX-2) inhibitors in clinical practice are minimal because of several unresolved questions. Although these drugs have a similar efficacy as nonselective NSAIDs, the main concern for the use of COX-2 inhibitors is safety. The inhibitors have been associated with an increased risk of cardiovascular events. Celecoxib may be considered in select patients because it does not affect platelet function or directly increase the risk of bleeding.

Tramadol is a weak opioid agonist with 2 mechanisms of action: binding to the opioid μ receptor and inhibiting the reuptake of norepinephrine and serotonin. Tramadol theoretically possesses weak opioid activity, reducing the risk of respiratory depression. However, tramadol is a substrate for the CYP2D6 liver enzyme, so agents with the ability to induce or inhibit this enzyme may interact with tramadol. Clinicians should exercise caution in patients concurrently on selective serotonin reuptake inhibitors because of the risk of precipitating serotonin syndrome. There is a lack of evidence for the benefit of tramadol.

 However, no evidence supports the concept that tramadol is less addictive than opioids.

Camphor, menthol, methyl salicylate, and a combination of these can be useful in managing localized musculoskeletal injuries, particularly if they can be rubbed into the affected area. These agents can provide short-term relief of muscle pain. Many products are available over the counter and are inexpensive. However, they must be applied several times per day on intact skin. Furthermore, topical NSAIDs, such as diclofenac patches and gel, can also provide good pain relief and are generally underused, particularly in elderly adults.

For moderate to severe pain, opioids are a mainstay of therapy because they produce greater analgesia effects than acetaminophen and NSAIDs. Results from 2 recent studies measuring postoperative pain showed that combination treatment with a nonopioid analgesic such as acetaminophen produced superior analgesia compared with the opioid alone.

 There is limited evidence on whether AEs of the different agents vary at equianalgesic doses.

 In addition, in a meta-analysis, there was limited evidence to point to any individual agent that was more effective than morphine in reducing cancer-related pain, and because of a lack of studies comparing opioid agents in acute pain, a similar statement can be made.

Developed in 1986 to treat cancer pain, the World Health Organization (WHO) pain ladder is a validated instrument that is the backbone of pain management.

 Consisting of 3 steps ascending in the degree of pain severity, the pain ladder recommends specific pharmacologic treatments for each level of pain.

 It is also important to note that regardless of step, adjuvant therapy ranging from calcium channel blockers to tricyclic antidepressants is recommended as an add-on for additional pain relief. Adjuvants enhance the effects of nonopioid and opioid analgesics by targeting pain through a different mechanism, establishing the pain ladder’s alignment with the therapeutic strategy of multimodal analgesia.

For step 1, characterized as mild pain, treatment should consist of nonopioid analgesics including acetaminophen and NSAIDs. Patients inadequately controlled under step 1 or who have a more severe baseline level of pain should proceed to step 2 in the WHO pain ladder, which is labeled moderate pain. This step recommends therapy with a low-potency opioid, such as codeine or oxycodone, in combination with a nonopioid such as acetaminophen or an NSAID. Combinations of acetaminophen-containing opioid products can also be used to lessen the pill burden for patients. The third step, or the severe pain category, is for patients who are inadequately controlled by step 2 therapy. Patients in this category should be treated with a high-potency opioid, such as fentanyl, hydromorphone, or morphine, in combination with a nonopioid analgesic.

Balancing Opioid Drug Abuse With Pain Management

Because of the addictive properties of opioid analgesics, these medications can be abused. Results from a 2010 survey showed that an estimated 2 million people used prescription pain medications for nonmedical purposes.

 In the heat of the opioid epidemic, health care professionals face a difficult situation. However, it is important to realize that health care professionals can take small steps to reduce diversion and improve patient outcomes. Such steps include prescribing the minimally effective dose for opioids and encouraging patients to use 1 pharmacy for their medications.

Acute pain is a prevalent condition and has a significant impact on morbidity, quality of life, and health care costs in the United States. Acute pain management should focus on a multimodal approach of using medications of different classes to provide the best outcomes for patients.

Omama Zubairi is a PharmD candidate at the Ernest Mario School of Pharmacy at Rutgers University in Piscataway, New Jersey. Deepali Dixit, PharmD, BCPC, BCCCP, is a clinical associate professor at the Ernest Mario School of Pharmacy at Rutgers University. She is also a clinical pharmacy specialist, critical care, at Robert Wood Johnson University Hospital in New Brunswick, New Jersey.

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 Berlin, Germany: Springer; 2015:163-166.

Todd KH, Ducharme J, Choiniere M, et al. Pain in the emergency department: results of the pain and emergency medicine initiative (PEMI) multicenter study. 

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Apfelbaum JL, Chen C, Mehta SS, Gan TJ. Postoperative pain experience: results from a national survey suggest postoperative pain continues to be undermanaged. 

American Pain Society Quality of Care Committee. Quality improvement guidelines for the treatment of acute pain and cancer pain. 

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Carvalho B, Clark DJ, Angst MS. Local and systemic release of cytokines, nerve growth factor, prostaglandin E2, and substance P in incisional wounds and serum following cesarean delivery. 

2008;9(7):650-657. doi: 10.1016/j.jpain.2008.02.004. 

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Towheed TE, Maxwell L, Judd MG, Catton M, Hochberg MC, Wells G. Acetaminophen for osteoarthritis. 

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Marjoribanks J, Proctor M, Farquhar C, Derks RS. Nonsteroidal anti-inflammatory drugs for dysmenorrhoea. 

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Gibbison B, Bailey CR, Klein AA. Tramadol - the Marmite(™) drug. 

2015;70(2):125-130. doi: 10.1111/anae.12972.

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Substance Abuse and Mental Health Services Administration. Results from the 2010 national survey on drug use and health: summary of national findings. samhsa.gov/data/sites/default/files/NSDUHNationalFindingsResults2010-web/2k10ResultsRev/NSDUHresultsRev2010.pdf. Published September 2011. Accessed May 30, 2018.

Chronic Care Focus

Acute Pain Management in the General Population

USP Chapter 800 presents many challenges for pharmacies and other health care settings, especially compounding pharmacies. Let’s review air flow requirements for the hazardous drug (HD) compounding area and “powder hoods” in nonsterile compounding of hazardous preparations as defined by the National Institute for Occupational Safety and Health.

Although the requirements are easy to understand and straightforward, accomplishing the requisite specifications can be challenging and requires meticulous guidance and planning, along with significant expense.

There are 2 air flow areas to be considered (see Section 5.3.1, Table 2, Engineering Controls for Nonsterile HD Compounding, in the USP Chapter <800> guidelines). The first is air flow for the hazardous room known as the Compounding Secondary Engineering Control (C-SEC) room. The second is air flow for “powder hoods” or the Compounding Primary Engineering Control (C-PEC) room (see Appendix 3, “Types of Biological Safety Cabinets,” in the USP Chapter <800> guidelines).

There are 4 primary requirements that must be addressed in the C-SEC room:

Air from the room must be externally vented, meaning that it does not need to be filtered and must go outside.

The C-SEC must be physically separated from other preparation areas.

There must be 12 air changes per hour, at a minimum; the air in the room must be replaced 12 times per hour, or 1 air change every 5 minutes. The replacement air may come from adjoining areas of the building or from outside the building.

The room must have “negative pressure between 0.01 and 0.03 inches of water column relative to adjacent areas.” The rationale is to have net air continuously moving into the hazardous lab. If there is positive pressure inside the C-SEC room, it may be possible for hazardous chemicals to escape into surrounding areas. Measuring air pressure relative to surrounding areas can be accomplished with an inexpensive and simple gauge.

The standards regarding the C-SEC room are direct and, in theory, easy to implement. It is important to be familiar with the standards to be able to ascertain whether proposals meet the requirements. However, finding HVAC contractors familiar with their implementation and the appropriate equipment can pose a challenge. Equipment is available that will move air into and out of the room and provide a constant temperature in the room. At least 1 brand of unit that will meet the requirements exchanges a portion of the energy from the exhaust air to the intake air.

There are several considerations regarding the C-PEC room:

The powder hood must be in a C-SEC that meets the requirements noted earlier (see Section 5.3.1, paragraph 3, in the USP Chapter <800> guidelines).

Table 2 in the USP Chapter <800> guidlines notes that the powder hood can be externally vented inside the C-SEC. A single high-efficiency particulate air (HEPA) filter is sufficient if the hood vents outside the building. This is the preferred method of venting the powder hood.

If the powder hood vents inside the room, 2 redundant HEPA filters in series are required in the powder hood.

Unpacking of anti-neoplastic HDs and HD active pharmaceutical ingredients must be done in an area that has a negative or neutral pressure relative to surrounding areas (see Section 5.1, Receipt, in the USP Chapter <800> guidelines.)

It is important that pharmacies fully ascertain and understand the requirements contained in USP Chapter 800 prior to implementation to ensure that changes comply with the accepted standards, resulting in increased safety for patients and personnel. USP Chapter 800 primarily focuses on the safety of personnel. Being familiar with the standards will allow pharmacies to meet the standards but also prevent them from unintentionally exceeding the standards, resulting in unnecessary expense.

Douglas C. Higgins, RPh, FIACP, is the owner of Doug’s Compounding Pharmacy in Paxton, Illinois.

Safe Handling

USP Chapter 800 presents many challenges for pharmacies and other health care settings, especially compounding pharmacies.

USP Chapter : Nonsterile Compounding Pharmacy Air Flow Considerations

Health care providers participating in the 340B program are prohibited from contributing to duplicate discounts, or the scenario that exists when a manufacturer provides a discounted 340B price and a rebate to Medicaid for the same drug.

340B ceiling prices are calculated through use of the Medicaid unit rebate amount. Thus, when a manufacturer provides a rebate to Medicaid on a drug that has been sold to a covered entity at the 340B price, the manufacturer has essentially provided the rebate twice. The 

 details how 340B ceiling prices are calculated.

Duplicate discounts also can occur when a covered entity chooses to use 340B (carve in) for Medicaid patients and bills Medicaid.

 If a covered entity decides to carve in, it must have mechanisms, policies, and procedures in place to prevent duplicate discounts from occurring.

The Health Resources and Services Administration’s (HRSA) Office of Pharmacy Affairs (OPA) created the Medicaid Exclusion File (MEF) as a tool for stakeholders to use to prevent duplicate discounts from occurring for fee-for-service (FFS) Medicaid. The MEF lists covered entities that have chosen to use 340B drugs for their Medicaid patients or carve in by their respective Medicaid Provider Numbers and/or National Provider Identifiers. Covered entities must provide this information during the OPA’s 340B registration process and verify it annually during recertification. A covered entity may elect to change its carve in/out status at any time in a calendar quarter, but that change will not be effective until the start of the following quarter. The MEF can be used by manufacturers and states to identify claims from 340B-covered entities that contain drugs charges that should not be included in Medicaid rebate totals.

In addition to the MEF, states employ a variety of requirements to prevent duplicate discounts. Medicaid plans do not use a standard set of requirements for 340B-eligible medications between states, nor across retail or provider-administered drug settings. This is especially challenging for entities that treat Medicaid patients from different states. To alleviate some of this stress, the Centers for Medicare & Medicaid Services (CMS) published the Covered Outpatient Drug Final Rule requiring states to declare, if they had not already, how their Medicaid programs would reimburse retail claims under which 340B products were used.

In a retail pharmacy setting, covered entities may be required to submit information to Medicaid agencies during prescription claim adjudication using National Council for Prescription Drug Programs (NCPDP) standards. Information required in the claim may include any of the following:

Submission clarification code: 20. This code identifies the claim as a 340B eligible prescription.

340B actual acquisition or net cost. There may be variation between plans regarding the required NCPDP field used to submit 340B cost information.

In the provider-administered drug setting, claims may require a modifier. For example, some Medicaid agencies require a UD modifier on each Healthcare Common Procedure Coding System billing unit for drugs purchased at the 340B price.

 This modifier may be in addition to other modifiers required by CMS in patients who are Medicaid and Medicare beneficiaries.

 This information may be required for both FFS and managed care Medicaid organization (MCO) plans, depending upon the plan and state requirements. MCO and state plan requirements should also be reviewed regularly, because details may change.

If a possible duplicate discount occurs, covered entities should apply their standards for a material breach and follow their procedures within their policy. Regardless of material breach threshold, the covered entity is expected to resolve any discrepancies with the manufacturers.

Covered entities are responsible for maintaining accurate information on HRSA’s MEF and keeping auditable records. Covered entities that elect to carve in to Medicaid plans must have a detailed understanding of the MEF and any plan-specific Medicaid billing requirements for drugs purchased at a 340B price. Monitoring for potential duplicate discounts is also a critical component of the audit plan for covered entities. Covered entities that understand and audit for the variety of requirements can successfully position themselves to avoid duplicate discounts as part of the 340B Drug Pricing Program.

Christopher Loucks is the assistant director of pharmacy for supply chain at the University of Kansas Health System in Kansas City, Kansas.

Grayson K. Peek is the pharmacy manager for business development and integrity at Duke University Hospital in Durham, North Carolina.

Gavin Magaha is a manager of 340B education and compliance support at Apexus in Irving, Texas. 

Medicaid/duplicate discounts. Apexus website. 340bpvp.com/resource-center/faqs/medicaid--duplicate-discounts/. Accessed May 18, 2018.

Apexus. 340B Basics. 340B University: New Orleans, Louisiana. Presentation. December 6, 2015.

Health Resources and Services Administration. 340B OPAIS user guide for authorizing officials and primary contacts. 340bregistration.hrsa.gov/help/external/Resources/PDF%20User%20%20Guides/ExternalUserGuide.pdf?AspxAutoDetectCookieSupport=1. Accessed May 18, 2018.

Medicaid program; covered outpatient drugs. 

2016;81(20):5169-5357. Codified at 42 CFR §447.

Guidance documents. NCPDP website. ncpdp.org/Resources/Guidance-Documents. Accessed May 20, 2018.

Claims for drugs purchased through the 340B drug pricing program. ForwardHealth website. forwardhealth.wi.gov/WIPortal/Subsystem/KW/Print.aspx?ia=1&p=1&sa=48&s=4&c=13&nt=Claims%20for%20Drugs%20Purchased%20Through%20the%20340B%20Drug%20Pricing%20Program&adv=Y. Accessed May 22, 2018.

January 2018 Update of the Hospital Outpatient Prospective Payment System (OPPS). Medicare Learning Network. Centers for Medicare & Medicaid Services. MLN Matters Number: MM10417. Release Date: December 22, 2017.

Self-disclosure process. HRSA website. hrsa.gov/opa/self-disclosures/self-disclosure.html. Accessed May 20, 2018.

July 2018

Antimicrobial Stewardship Targets in Community-Acquired Pneumonia

Acute Pain Management in the General Population

USP Chapter : Nonsterile Compounding Pharmacy Air Flow Considerations

340B Compliance: The Medicaid Exclusion File and Prevention of Duplicate Discounts

Overview of Heart Failure Pharmacotherapy

Risks, Diagnosis, and Treatment of Non-Hodgkin Lymphoma

Pharmacogenomics, Enzyme Competition, and the Evolution of Precision Prescribing

Precision Pharmacotherapy: Ready for Prime Time?