A 27-year-old white woman with a past medical history of intravenous drug abuse and hepatitis C presented to the emergency department with a 4-day history of severe chest pain, shortness of breath, and vomiting. She had been admitted earlier in the month with methicillin-resistant 

 (MRSA) endocarditis and signed herself out against medical advice without completing antibiotic therapy. Blood cultures confirmed MRSA and she was again diagnosed with MRSA endocarditis. Pharmacy staff performed medication reconciliation and all home medications were resumed, including Xarelto (rivaroxaban). Pharmacy staff did not see an indication for Xarelto and investigated further.

Upon investigation, pharmacy staff discovered the patient had a diagnosis of protein S deficiency. Protein S deficiency is a type of inherited thrombophilia associated with increased risk of venous thromboembolism (VTE). Protein S is an endogenous vitamin K—dependent anticoagulant that acts as a nonenzymatic cofactor for activated protein C (aPC).

 The primary effect of aPC is to inactivate coagulation factors Va and VIIIa, which help activate factors II and X, respectively. Inactivating factors II and X halts the clotting cascade; however, a deficiency in protein S would diminish this effect and cause a procoagulant state.

Is Xarelto the best therapeutic option for this patient? Given the patient’s history of noncompliance with her antibiotic and anticoagulation/ antithrombotic therapy, warfarin would not be a good option due the importance of compliance with the medication, the need for bridging anticoagulation, and the required periodic international normalized ratio monitoring.

 Xarelto is a factor Xa inhibitor, and newer agents such as oral direct thrombin and factor Xa inhibitors are gaining in popularity for the treatment of VTE and for VTE prophylaxis in patients without inherited thrombophilia. There are no data that prove the newer agents are any less safe or effective than warfarin treatment in these patients.

Since the patient is of childbearing age and warfarin is pregnancy category X, warfarin would not be a good option. Pradaxa (dabigatran), a direct thrombin inhibitor, would be a safe and effective option; however, it requires twicedaily dosing for VTE prophylaxis, which would present a compliance issue for this patient. Eliquis (apixaban), a factor Xa inhibitor, is a pregnancy category B drug, but it also requires twice-daily dosing and would pose a compliance issue for this patient.

 The pharmacist concluded that Xarelto, which is pregnancy category C, was the best therapeutic option for this patient due to its once-daily dosing for VTE prophylaxis, lack of monitoring requirements, and more desirable pregnancy category.

Jerry Barbee, PharmD, BCPS, is a clinical pharmacist at HCA West Florida Hospital. Jaclyn Chessher, PharmD, is a clinical pharmacist at HCA West Florida Hospital. Ambree Gober is a 2015 PharmD candidate at Auburn University’s Harrison School of Pharmacy. Matt Savoie is a 2015 PharmD candidate at Auburn University’s Harrison School of Pharmacy.

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Pharmacotherapy: A Pathophysiologic Approach

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		Apixaban, dabigatran, rivaroxaban, warfarin. In: Clinical Pharmacology [online database]. Tampa, FL: Elsevier Gold Standard, Inc; 2015. www.clinicalpharmacology-ip.com/default.aspx.

Articles

Pharmacist Rounds

Protein S deficiency is a type of inherited thrombophilia associated with increased risk of venous thromboembolism.

Protein S Deficiency

Cholestasis is a serious complication of long-term parenteral nutrition use.

Parenteral nutrition (PN) is a life-saving therapy for patients unable to meet nutritional needs by mouth.

 Today, over 30,000 patients depend on long-term PN and more than 350,000 patients receive PN on a yearly basis.

 Although these figures represent patients of all ages, many pediatric patients depend on PN for survival, particularly those with intestinal failure/short-bowel syndrome (SBS).

PN is a method of intravenous (IV) delivery of nutrients, specifically macronutrients (amino acids, dextrose, IV fat emulsion [IVFE]), micronutrients (vitamins, minerals, trace elements and electrolytes), and fluids that are individually tailored to meet a patient’s daily nutritional requirements.

 Although PN has revolutionized the care of pediatric patients unable to meet nutritional requirements enterally, chronic use may lead to several complications including nutritional deficiencies, electrolyte abnormalities, infections, metabolic bone disease, and PN-associated cholestasis (PNAC).

PNAC is one of the most challenging morbid complications associated with PN. The incidence of PNAC ranges from 7.4% to 84%; this wide range is due to the heterogeneity of study subjects, differences in definitions of PNAC, and variation of composition and duration of PN therapy described in the literature.

 When PNAC develops, it is a predictor of mortality and morbidity; up to one-third of surgical neonates who develop PNAC are at risk of mortality, and in patients with SBS, PNAC is the greatest risk factor for mortality.

PNAC is clinically characterized by elevations in liver enzymes. Prolonged PN use (>2 weeks) is associated with cholestasis that may progress to liver failure if not treated appropriately.

 Biochemical markers of PNAC include elevations is serum gamma-glutamyl transpeptidase and serum bilirubin. Serum direct (conjugated) bilirubin >2 mg/dL is commonly used as a marker of PNAC.

 Signs and symptoms may also include jaundice, hepatosplenomegaly, and ascites.

The causes of PNAC are multifactorial and include prematurity, lowbirth weight, prolonged duration of PN, lack of enteral feeding, development of sepsis, bacterial overgrowth, and the presence of SBS.

 An additional and independent risk factor is the administration of soybean-based IVFE at standard doses (up to 3 g/kg/day). Soybean-based IVFE is the only IVFE approved by the FDA for use in pediatric patients.

 The exact mechanism by which soybean-based IVFE is believed to contribute to PNAC is unknown, but several mechanisms have been proposed, including the presence and proinflammatory effects of omega-6 fatty acids; the presence of phytosterols, which can impair bile drainage; a direct effect on the hepatocytes; and cell membrane peroxidation.

Nutrition support providers are thus caught between a rock and a hard place. IVFE is a critical component of PN solutions due the provision of calories and energy and its role in preventing the development of essential fatty acid deficiency (minimum dose required is 0.5-1 g/kg/day). However, providing soybean- based IVFE is an independent risk factor for the development of PNAC. While IVFE cannot be removed from PN solutions, there are 2 approaches to managing this conundrum that will be discussed: (1) the use of alternative source IVFE and (2) soybean-based IVFE dose minimization.

Although not approved for use in the United States in pediatric patients, olive oil—containing fat emulsions have been evaluated in the setting of PNAC. A prospective, randomized, double-blind trial in patients younger than 10 years of age on PN for at least 3 months showed a similar incidence of PNAC in patients who received an olive oil–based IVFE (1.92 ± 0.17 g/kg/day) compared with those who received soybean-based IVFE (1.69 ± 0.15 g/kg/ day).

 Two similar studies conducted in neonates and infants also showed similar incidences of PNAC in those who received olive oil—based IVFE compared with those who received soybean-based products.

All 3 of these studies have limitations, namely short study duration, small numbers of patients, and study design. Although olive oil—based IVFE provides an interesting alternative to soybean-based fat emulsions, the presence of phytosterols and omega-6 fatty acids may still be problematic to the liver, even though the content of these is less than what is found in soybean-based IVFE. Further research is needed with these emulsions to fully understand the potential benefit they may have in the PNAC setting.

Another alternative source emulsion is the composite emulsion SMOFlipid.

 Also not approved for use in the United States, this is a combination of soybean oil, medium-chain triglycerides, olive oil, and fish oil. In a single-center, double-blind, randomized prospective cohort, pediatric patients 5 months to 11 years of age received either SMOFlipid (2 g/kg/day, 4-5 times per week) or soybean-based IVFE (2 g/kg/day, 4-5 times per week).

 The patients receiving SMOFlipid experienced a decrease in total bilirubin over the course of the 29-day study, whereas those receiving soybean-based IVFE had an increase in their total bilirubin (

 <.01). The benefit of SMOFlipid has also been demonstrated in several case series.

 These favorable results indicated that SMOFlipid may play a beneficial role in the management of PNAC, although long-term effects remain unknown. The benefits seen are theorized to be due to the decreased amounts of phytosterols and omega-6 fatty acids; the addition of omega-3 fatty acids from the fish oil component, which may have anti-inflammatory properties; or both.

The fish oil—based fat emulsions contain mostly omega-3 fatty acids. Additionally, higher levels of alphatocopherol, an antioxidant, are present. Taken together, these components may be responsible for the anti-inflammatory properties and purported beneficial effects of fish oil–based emulsions in the setting of PNAC.

Fish oil—based emulsions have been shown to be beneficial in reversing PNAC in several case reports as well as small cohort studies.

 In an openlabel, prospective, cohort study, infants predicted to need a minimum of 30 days of PN who developed PNAC were switched to fish oil at a dose of 1 g/kg/day and compared with a cohort that remained on soybean-based IVFE at a dose of 1 to 4 g/kg/day.

 Reversal of cholestasis occurred in 45% of the patients receiving fish oil compared with 4.1% of those receiving soybean-based IVFE (P <.0001). Further, the risk of death and the need for liver transplantation were also lower in the fish oil group. These results have been corroborated by several other studies.

Although fish oil— based emulsions show promise in reversing PNAC, data are limited by study design, small sample sizes, short duration and, importantly, by the fact that the studies use a reduced dose of fish oil (1 g/kg/day). It is unknown whether the positive effects seen correspond to the presence of omega-3 fatty acids, the reduced dose, or both. Fish oil–based fat emulsions are not approved for use in the United States but can be obtained through compassionate-use protocols.

As the above fat emulsions are not readily available in the United States, many centers have implemented dose-minimization techniques with the goal of maintaining growth and development, preventing the development of essential fatty acid deficiency, and reducing the risk of PNAC. Soybean-based IVFEs are usually dosed at 2 to 3 g/kg/day; dose-minimization techniques involve dosing at ≤1 g/kg/day.

The benefit of dose minimization was demonstrated in animals as well as in adults in the early 1980s,

 although it was not until 2000 that it was first described in pediatric patients.

 Since then, the benefit of dose minimization has been demonstrated for the treatment of PNAC.

In a single-institution prospective study with a matched historical cohort, infants with PNAC were transitioned from a standard dose (2-3 g/kg/day) to a minimized dose (1 g/kg/day twice weekly) and compared with a wellmatched historical control that continued to receive the standard dose.

 Infants who received the reduced dose experienced a significant decrease in direct bilirubin over the course of the study compared with those who received standard dosing (

 = .0017). Forty-two percent achieved direct bilirubin <2.5 mg/dL compared with 10% in the standard group (

 = .013). Importantly, some patients in the study developed a mild essential fatty acid deficiency that was reversed when the dose was increased to 1 g/kg/day 3 days per week. As such, some institutions now use a dose of 1 g/kg/day thrice weekly for the treatment of PNAC once it develops.

Dose reduction has also been investigated for the prevention of PNAC. Several retrospective studies and 1 small prospective pilot study have been published evaluating a dose of 1 g/kg/day compared with standard dosing for the prevention of PNAC with positive results.

 However, data are limited by retrospective study design, small sample size, short duration, and lack of long-term follow-up.

Whereas soybean-based fat emulsion minimization strategies appear to be efficacious for both prevention and treatment of PNAC, there are several unanswered questions regarding optimal timing of dose reduction; ideal dosing strategy; long-term data, specifically on neurodevelopmental followup; and comparative efficacy with the alternative fat emulsions.

PNAC is a serious problem affecting pediatric patients who depend on longterm PN. The uses of alternative IVFE and/or soybean-based IVFE dose minimization appear to be efficacious for the management of PNAC. However, data supporting either approach rely mostly on retrospective or uncontrolled studies, therefore limiting the strength of supporting evidence. The American Society for Parenteral and Enteral Nutrition (ASPEN) has called for more research in this field. ASPEN recognizes soybean-based IVFE dose minimization as a reasonable approach to managing PNAC in patients with intestinal failure; however, more information is needed regarding the olive oil, fish oil, and composite fat emulsions before recommendations can be made, especially since these products are not approved for use in the United States.

 Expert opinion holds that both the use of alternative IVFE and soybean- based IVFE dose minimization are superior to conventional therapy and that similar estimates of efficacy between the 2 are expected.

 Before conclusions can be drawn regarding either approach, comparative data from well-designed studies are needed. In addition, expansion of available IVFE products in the United States is necessary.

Dr. Blackmer is an assistant professor of pharmacy at the University of Colorado Skaggs School of Pharmacy and Pharmaceutical Sciences and a clinical pharmacy specialist at Children’s Hospital Colorado. She has practice and research interests in fluids, electrolytes, and nutrition and is particularly interested in investigating complications associated with the long-term administration of parenteral nutrition. Additionally, she has practice and research interests in the care of chronically ill children and children with medical complexity.

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. 2015;60(6):702-707. doi: 10.1097/MPG.0000000000000739.

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		Goulet O, Antebi H, Wolf C, et al. A new intravenous fat emulsion containing soybean oil, medium-chain triglycerides, olive oil, and fish oil: a single-center, double-blind randomized study on efficacy and safety in pediatric patients receiving home parenteral nutrition. 

. 2010;34(5):485-495. doi: 10.1177/0148607110363614.

		Muhammed R, Bremner R, Protheroe S, Johnson T, Holden C, Murphy MS. Resolution of parenteral nutrition—associated jaundice on changing from a soybean oil emulsion to a complex mixed-lipid emulsion. 

. 2012;54(6):797-802. doi: 10.1097/MPG.0b013e3182447daf.

		Ferreira N, Falconer J, Harley C, Rawat D, Fell J, Koglmeier J. Improved serum bilirubin with SMOF lipid in children with intestinal failure on long term parenteral nutrition. Paper presented at: British Society of Paediatric Gastroenterology, Hepatology and Nutrition Winter Meeting; January 28-30, 2009; Sheffield, England.

		Anish A, Lawson A, Cram H, et al. SMOF lipid in intestinal failure associated liver disease: experience in a regional centre. Paper presented at: British Society of Paediatric Gastroenterology, Hepatology and Nutrition Winter Meeting; January 27-29, 2010; Liverpool, England.

		Tillman, EM, Helms RA. Omega-3 long chain polyunsaturated fatty acids for treatment of parenteral nutrition—associated liver disease: a review of the literature. 

		Diamond IR, Pencharz PB, Feldman BM, Lin SC, Moore AM, Wales PW. Novel lipid-based approaches to pediatric intestinal failure—associated liver disease. 

. 2012;166(5):473-478. doi: 10.1001/archpediatrics.2011.1896.

		Meisel JA, Le HD, de Meijer VE, et al. Comparison of 5 intravenous lipid emulsions and their effects on hepatic steatosis in a murine model. 

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. 2008;121(3):e678-e686. doi: 10.1542/peds.2007-2248.

		Cheung HM, Lam HS, Tam YH, Lee KH, Ng PC. Rescue treatment of infants with intestinal failure and parenteral nutrition-associated cholestasis (PNAC) using parenteral fish-oil based lipid. 

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		Ekema G, Falchetti D, Boroni G, et al. Reversal of severe parenteral nutrition-associated liver disease in an infant with short bowel syndrome using parenteral fish oil (omega-3 fatty acids). 

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		Puder M, Valim C, Meisel JA, et al. Parenteral fish oil improves outcomes in patients with parenteral nutrition-associated liver injury. 

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		Calkins KL, Dunn JC, Shew SB, et al. Pediatric intestinal failure-associated liver disease is reversed with 6 months of intravenous fish oil. 

. 2014;38(6):682-692. doi: 10.1177/0148607113495416.

		Premkumar MH, Carter BA, Hawthorne KM, King K, Abrams SA. High rates of resolution of cholestasis in parenteral nutrition-associated liver disease with fish oil-based lipid emulsion monotherapy. 

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		Allardyce DB. Cholestasis caused by lipid emulsions. 

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Clinical Care Focus

Parenteral Nutrition: Complications of Long-Term Use in Pediatric Patients

Pharmacists can help minimize risk for patients using pain medications.

There are currently more than 100 million Americans suffering from chronic pain, including 65% to 80% of terminal cancer patients, 62% of nursing home residents, and many others who must combat pain on a daily basis.

 Chronic pain afflicts more patients in the United States than diabetes, coronary heart disease, stroke, and cancer combined.

 It reduces a patient’s independence and ability to perform many daily activities and puts a strain on social relationships, mood, and sleep patterns.

This decrease in overall functioning places a burden on the national economy, with total annual costs of health care and lost productivity attributable to pain ranging from $560 billion to $635 billion (2010 dollars) in the United States.

 With the number of patients suffering from pain increasing as the US population ages, the demand for pain management pharmacists will continue to rise.

The most widely accepted definition of pain is “an unpleasant sensory and emotional experience that is associated with actual or potential tissue damage or described in such terms.”

 There are, however, as many different definitions of pain as there are ways that pain can manifest itself in complex patients. Each directly influences the course of therapy for each individual.

Pain is classified by its duration and etiology. Duration of pain is classified in 2 categories: acute pain and chronic pain. Acute pain is a response to injury or tissue damage that generally does not last longer than it takes for normal healing to occur. Typically, this pain lasts less than 6 months, but may become chronic if not adequately treated. Chronic pain, on the other hand, persists longer than the normal course of time associated with injury, typically more than 3 to 6 months. In many cases, the initial injury may not be readily identifiable.

There are several etiologies of pain, including nociceptive pain and neuropathic pain. Nociceptive pain includes somatic pain, which arises from injury to body tissues and tends to be localized but varies in description and experience. Visceral pain is a nociceptive pain arising from the viscera mediated by stretch receptors; it is poorly localized, deep, dull, and cramping.

 Neuropathic pain manifests itself in abnormal neural activity secondary to disease, injury, or dysfunction of the nervous system. This type of pain can arise from the peripheral nervous system or the central nervous system.

Pain varies greatly in duration and etiology and often progresses or regresses as the pathology of the patient’s injury or disease state changes. In many cases, especially in chronic pain patients, complex pain states do not exist as a single well-defined pain, but rather as a mix of several types of pain.

There are many medications used to treat the various etiologies of pain. To maximize efficacy and minimize risk, therapies should be individualized for each patient’s pathology. The goal of proper pain management should always be to improve the patient’s quality of life, decrease the average pain rating, and improve overall functioning. Pharmacists must do their best to minimize patient risk associated with pain management. Proper medication therapy can reduce addiction, short- and long-term adverse effects, and risk of overdose.

For patients suffering from neuropathic pain including, but not limited to, peripheral neuropathic pain (eg, diabetic neuropathy, radiculopathy, postherpetic neuralgia) and central neuropathic pain (eg, post stroke pain, Parkinson’s disease pain, spinal cord injury pain, HIV myelopathy), there are many potential appropriate treatment options. These medications include tricyclic antidepressants, anticonvulsants, gabapentin, pregabalin, selective serotonin reuptake inhibitors, N-methyl-D-aspartate antagonists, topical lidocaine and capsaicin, opioid analgesics, and tramadol. It is the pharmacist’s responsibility to evaluate these medications. Pharmacists play a pivotal role in determining drug efficacy and in monitoring the side effects and interactions of multiple medications to help patients achieve good therapeutic outcomes.

When patients suffer from nociceptive pain, including somatic and visceral pain, certain classes of medications tend to have higher efficacy. These nociceptive pain medications include acetaminophen, nonsteroidal anti-inflammatory drugs, topical lidocaine, capsaicin, corticosteroids, skeletal muscle relaxants, opioid analgesics, and tramadol. Patients taking these medications need to be closely monitored by the pharmacist to ensure both dose and agent are appropriate for the patient’s comorbidities, age, and other possible medication interactions.

It is crucial that the pharmacist always perform a quick equianalgesic calculation to ensure that a patient’s new opioid medication is at a safe and effective dose (Online Table 1). When using the equianalgesic chart, an incomplete cross-tolerance dose reduction of 25% to 50% may be appropriate.

Pharmacist involvement can especially affect outcomes in pain management for patients with multiple disease states taking multiple medications for multiple types of pain. The incidence of adverse medication events is reduced with pharmacist intervention.

Nobody deserves to live with severe pain. Pharmacists can help patients live meaningful and productive lives with adequately managed pain. It is the responsibility of pharmacists to monitor patients’ 4 As: analgesia, activities of daily living, adverse events, and aberrant drug behaviors.

 Proper pain assessment is essential for understanding patients’ pain and providing highly effective treatment while simultaneously minimizing risk.

Assessment and proper planning can also help minimize patient risk. This can start with “The 10 Steps of Universal Precautions in Pain Medicine” (Online Table 2). By applying these recommendations, stigma is reduced and overall outcomes are improved.

Chronic Care Focus

Pain Management: The Pharmacist's Evolving Role

In an acclaimed session at the American Society of Health-System Pharmacists’ 2015 Summer Meetings and Exposition in Denver, Tom Frank, PharmD, BCPS, of the Department of Pharmacy Practice at the University of Arkansas for Medical Sciences, walked health-system pharmacists through the new drugs for 2015 they can expect to handle.

Dr. Frank provided attendees with a detailed list of 22 new medications, describing the indications, pharmacology, adverse effects, dosing, and associated costs for each.

		Ledipsavir and sofosbuvir (Harvoni) by Gilead

		Ombitsavir, paritaprevir co-dosed with ritonavir, and dasabuvir (Viekira PAK) by AbbVie

All 3 of these HCV drugs are characterized by shorter treatment durations and improved efficacy and safety profiles. However, Dr. Frank said, the high costs associated with chronic HCV treatments should prompt pharmacists to reconsider their formula for determining the drugs’ worth.

		Empagliflozin (Jardiance) by Boehringer Ingelheim and Lilly

		Albiglutide (Tanzeum) by GlaxoSmithKline

		Insulin inhalation powder (Afrezza) by Sanofi and MannKind

The standout in this new class of diabetes drugs is Afrezza, the first and only FDA-approved insulin for administration by inhalation. Although it was approved to treat both type 1 and type 2 diabetes, type 1 diabetics must use it in conjunction with long-acting insulin.

 the health-system pharmacist’s role is “very important” for ensuring patient adherence to novel oral anticoagulants like edoxaban, because the drugs have a short half-life.

“If you have somebody on a once- or twice-a-day dose [of edoxaban] that runs out of the prescription on Saturday and won’t refill until Monday…an atrial fibrillation patient may very well may have a stroke on Sunday,” he said.

		Oritavancin (Orbactiv) by The Medicines Company

“The [health care] landscape has a lot of activity in terms of anti-infectives, specifically antibacterials—primarily for skin and skin-structure infections,” Dr. Frank told attendees.

		Naltrexone and bupropion (Contrave) by Orexigen and Takeda

Contrave’s active ingredients, naltrexone and bupropion, are an opioid antagonist and antidepressant, respectively. As a result, Dr. Frank explained, patients taking chronic opioid therapy should not take Contrave, and patients receiving acute opioid treatment may not achieve that regimen’s full benefits if they also take Contrave. In the development pipeline, Dr. Frank forecasted that certain drugs currently in the development pipeline would likely be significant for health-system pharmacists’ practice in the near future.

“There are 2 monoclonal antibodies that are just around the corner that are going to be used to reduce [low-density lipoprotein] cholesterol…beyond what we’ve been able to do,” he said.

Dr. Frank also mentioned Novartis’s investigational LCZ696 as a potential new heart failure strategy. “I expect, by this time next year, we will probably be talking about these [drugs] in terms of, ‘These are really impressive additions.’”

News & Highlights

Here are new drugs for 2015 that pharmacists can expect to handle.

New Drugs Health-System Pharmacists Should Know

Health-system pharmacists can play a pivotal role in ensuring medication adherence among anticoagulated patients during transitions of care (TOC).

In a session dedicated to this topic at the American Society of Health-System Pharmacists’ 2015 Summer Meetings and Exposition in Denver, John Moorman, PharmD, BCPS, of the Department of Pharmacy Practice at Northeast Ohio Medical University, said pharmacists can implement a number of interventions to safeguard a TOC program’s success. Studies have shown pharmacist-led interventions are successful in supporting patient adherence to novel oral anticoagulants (NOACs) and improving health outcomes.

The results of one study demonstrated that adherence rates for atrial fibrillation patients taking the NOAC dabigatran (Pradaxa) were stronger among those participating in a pharmacist-driven drug management program. This outcome was attributed to pharmacists’ ability to provide education regarding medication adherence, examine any possible drug interactions, follow-up to ensure patients are sticking to their regimens, and confirm prescriptions are refilled on time.

Mollie Ashe Scott, PharmD, regional associate dean for the Asheville campus of the UNC Eshelman School of Pharmacy, exclusively told 

 about her health-system’s approach to a pharmacist-led TOC program for patients taking NOACs.

“[Mountain Area Health Education Family Health Center] has some automated systems in place where patients who are in our hospital system will transition to the pharmacist for management of anticoagulation, perhaps before they even see their physician, in order to get that plan implemented and ensure safety of the use of anticoagulants,” Dr. Scott explained. In this particular TOC model, pharmacists are tasked with giving patients an overview of their anticoagulant treatment plan.

“As the patient is being discharged, regardless of what anticoagulant they’re on, the system gets them in front of a pharmacist embedded within the clinic for follow-up, for education, for issues with adherence, for issues with cost, for development of the monitoring plan over time, and to develop a stop date in terms of the length of therapy,” she said.

Personalized attention from a pharmacist is especially important when considering the number of anticoagulants currently available and deciding which treatment regimen is most appropriate for a particular patient.

“[Comparing NOACs] with warfarin is a very important conversation because there’s not a one-size-fits-all strategy with those particular therapies,” Tom Frank, PharmD, BCPS, of the Department of Pharmacy Practice at the University of Arkansas for Medical Sciences, told 

For instance, patients may be more likely to remain compliant with their anticoagulant treatment regimen if it is relatively convenient. This is one strength of NOACs like edoxaban (Savaysa), which “offers the convenience of once-daily dosing, no need for routine blood monitoring, and the flexibility to be taken with or without a meal,” Howard Rutman, MD, vice president of medical affairs for the drug’s manufacturer, Daiichi Sankyo, told 

For many anticoagulated patients, adherence is also dependent on treatment costs, and the results of a sub-group analysis from the Hokusai-VTE trial presented in a poster at the ASHP 2015 Summer Meetings suggest edoxaban is a cost-saving alternative to warfarin.

In addition to cost effectiveness, Dr. Frank said, “NOACs are desirable [for patients] because 2 hours after you take the first dose, you are anticoagulated."

Regardless of which NOAC is ultimately selected, Dr. Frank said “it’s imperative that [health-system pharmacists] have a level of communication and access for the patients in order to predispose them to success with this very important therapeutic tool.”

Health-system pharmacists can play a pivotal role in ensuring medication adherence among anticoagulated patients during transitions of care.

Care Transitions in Anticoagulated Patients: The Health-System Pharmacist's Role

Provider status legislation may be the signature pharmacy policy issue of 2015. In a session at the American Society of Health-System Pharmacists (ASHP) 2015 Summer Meetings and Exposition in Denver, several ASHP policy experts outlined critical pharmacy issues being addressed at various levels of government. A large portion of this session was devoted to discussing provider status for pharmacists.

“Provider status is the biggest legislative issue in pharmacy right now…across the board,” Chris Topoleski, director of federal regulatory affairs for ASHP, told 

 in an exclusive interview. “Virtually every pharmacy group is really focused on this.”

On the federal level, the Pharmacy and Medically Underserved Areas Enhancement Act was recently reintroduced in the US Senate and House of Representatives. The federal companion bills, HR 592 and S 314, enjoy bipartisan co-sponsorship and focus on medically underserved areas as defined by the Health Resources and Services Administration, explained Joseph Hill, MA, ASHP’s assistant director for government affairs and director of federal legislative affairs.

Beyond meeting a medical need, the legislation would amend Medicare Part B rules to allow pharmacists to receive payment for their care services, thereby increasing patients’ access to essential services, including health and wellness screenings and chronic disease management. Topoleski told 

 the legislation focuses on allowing “pharmacists to practice for Medicare beneficiaries in medically underserved areas and medically underserved populations,” so the provider status movement “isn’t looking to compete with primary care.”

On the state side, ASHP’s director of state, grassroots, and political action, Nicholas Gentile, told session attendees that all state legislatures and regulatory bodies must review their scope of pharmacy practice and then expand it to incorporate more patient care services that licensed pharmacists can perform. This is because the language from the proposed federal provider status legislation includes “…which the pharmacist is legally authorized to perform in the State in which the individual performs such services.”

, Gentile said generalizing state-level trends or updates on the provider status movement is “difficult” because the policy is a “moving target.”

“States deal with provider status in many different ways,” he said, noting popular methods include robust collaborative practice agreements and advanced credentialing. In the policy session, however, Gentile did explain what a good state provider status law should cover.

This includes the ability for a pharmacist to perform patient assessments, administer immunizations, provide medication therapy management services, manage drug therapy for chronic disease states, and initiate, adjust, or discontinue medications pursuant to collaborative drug therapy management.

Provider status legislation may be the signature pharmacy policy issue of 2015. 

July 2015

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Pain Management: The Pharmacist's Evolving Role

New Drugs Health-System Pharmacists Should Know

Care Transitions in Anticoagulated Patients: The Health-System Pharmacist's Role

Provider Status Dominates Pharmacy Policy Agenda

Antimicrobial Stewardship Efforts Advance in US Health Systems

Entyvio by Takeda Pharmaceuticals

ASHP 2015 Summer Meetings: Takeaways for Health-System Pharmacists