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Specialty Pharmacy Continuum • September/October 2020
CLINICAL
PAPs Breathe Life Into Asthma/COPD Care Patients with asthma and chronic obstructive pulmonary disease (COPD) who are enrolled in patient assistance programs (PAPs) for long-term medications are less likely to be hospitalized or visit the emergency department (ED), according to a study by Georgia pharmacists. Looking at records from 56 patients with COPD or asthma at Piedmont Athens Regional Medical Center who obtained medication through a PAP from January
2018 through March 2019, researchers found that the number of cumulative ED visits decreased from 54 in the six months before PAP enrollment to seven in the
SMOFLIPID (lipid injectable emulsion), for intravenous use BRIEF SUMMARY OF PRESCRIBING INFORMATION This brief summary does not include all the information needed to use SMOFlipid safely and effectively. Please see full prescribing information, including Boxed Warning for Smoflipid (lipid injectable emulsion), for intravenous use at www.freseniuskabinutrition.com/products/smoflipid.
>(9505.! +,(;/ 05 79,;,94 05-(5;: +LH[OZ PU WYL[LYT PUMHU[Z HM[LY PUM\ZPVU VM PU[YH]LUV\Z SPWPK LT\SZPVUZ OH]L ILLU YLWVY[LK PU [OL TLKPJHS SP[LYH[\YL (\[VWZ` ÄUKPUNZ PUJS\KLK PU[YH]HZJ\SHY MH[ HJJ\T\SH[PVU PU [OL S\UNZ 7YL[LYT PUMHU[Z HUK SV^ IPY[O ^LPNO[ PUMHU[Z OH]L WVVY JSLHYHUJL VM PU[YH]LUV\Z SPWPK LT\SZPVU HUK PUJYLHZLK MYLL MH[[` HJPK WSHZTH SL]LSZ MVSSV^PUN SPWPK LT\SZPVU PUM\ZPVU INDICATIONS AND USAGE SMOFlipid is indicated in adults as a source of calories and essential fatty acids for parenteral nutrition (PN) when oral or enteral nutrition is not possible, insufficient, or contraindicated. Limitations of Use: The omega-6: omega-3 fatty acid ratio and Medium Chain Triglycerides in SMOFlipid have not been shown to improve clinical outcomes compared to other intravenous lipid emulsions. Cumulative ED
six months after enrollment. Cumulative hospitalizations during the same time frame dropped from 13 to zero. “Having access to the medication was a huge contributor” to the results, said lead author Brooke Gallman, PharmD, a PGY-1 resident at the 360-bed nonprofit hospital and referral center. “Most of these patients were not able to afford inhalers prior to enrolling in the program, so they were having a lot of exacerbations. Every
aluminum at greater than 4 to 5 mcg/kg/day can accumulate aluminum to levels associated with central nervous system and bone toxicity. Tissue loading may occur at even lower rates of administration of PN products. • Risk of Parenteral Nutrition-Associated Liver Disease (PNALD): PNALD has been reported in patients who receive PN for extended periods of time, especially preterm infants, and can present as cholestasis or steatohepatitis. The exact etiology is unknown and is likely multifactorial. Intravenously administered phytosterols (plant sterols) contained in plant-derived lipid formulations have been associated with development of PNALD, although a causal relationship has not been established. If SMOFlipid-treated patients develop liver test abnormalities, consider discontinuation or dose reduction. • Hypertriglyceridemia: Impaired lipid metabolism with hypertriglyceridemia may occur in conditions such as inherited lipid disorders, obesity, diabetes mellitus, and metabolic syndrome. • Monitoring/Laboratory Tests: Routinely monitor serum triglycerides, fluid and electrolyte status, blood glucose, liver and kidney function, blood count including platelets, and coagulation parameters throughout treatment. Monitoring patients for signs and symptoms of essential fatty acid deficiency (EFAD) is recommended. • Interference with Laboratory Tests: Content of vitamin K may counteract anticoagulant activity. The lipids contained in this emulsion may interfere with some laboratory blood tests (e.g., hemoglobin, lactate dehydrogenase [LDH], bilirubin, and oxygen saturation) if blood is sampled before lipids have cleared from the bloodstream.
Piedmont Athens PAP Successes:
ADVERSE REACTIONS
visits decreased Most common adverse drug reactions >1% of patients who received SMOFlipid from clinical trials were nausea, vomiting, hyperglycemia, flatulence, pyrexia, from 54 to seven
DOSAGE AND ADMINISTRATION abdominal pain, increased blood triglycerides, hypertension, sepsis, dyspepsia, The recommended daily dosage in adults is 1 to 2 grams/kg per day and should not urinary tract infection, anemia and device-related infection. Cumulative exceed 2.5 grams/kg per day. SMOFlipid 1000 mL is supplied as a Pharmacy Bulk hospitalizations Package for admixing only and is not for direct infusion. Prior to administration, Less adverse reactions in ) 1% of patients who received SMOFlipid were dropped from 13common to zero transfer to a separate PN container. dyspnea, leukocytosis, diarrhea, pneumonia, cholestasis, dysgeusia, increased blood alkaline phosphatase, increased gamma-glutamyltransferase, increased Median amount billed per patient CONTRAINDICATIONS C-reactive protein, tachycardia, liver function test abnormalities, headache, pruritis, Known hypersensitivity to fish, egg, soybean, or peanut protein, or to any of the fromdizziness, decreased $4,683rash toand $0thrombophlebitis. active ingredients or excipients. The following adverse reactions have been identified during post-approval use of Severe hyperlipidemia or severe disorders of lipid metabolism with serum Median hospital acquisition cost per SMOFlipid in countries where it is registered. Infections and Infestations: infection. triglycerides > 1,000 mg/dL. person dropped from $351Thoracic to $0and Mediastinal Disorders: dyspnea. Respiratory, WARNINGS AND PRECAUTIONS To report SUSPECTED ADVERSE REACTIONS, contact Fresenius Kabi USA, • Death in Preterm Infants: (see BLACK BOX WARNING) LLC, at 1-800-551-7176, option 5, or FDA at 1-800-FDA-1088 or • Hypersensitivity Reactions: SMOFlipid contains soybean oil, fish oil, and egg www.fda.gov/medwatch. phospholipids, which may cause hypersensitivity reactions. Cross reactions DRUG INTERACTIONS have been observed between soybean and peanut oil. Signs or symptoms Coumarin and Coumarin Derivatives, Including Warfarin: Anticoagulant activity of a hypersensitivity reaction may include: tachypnea, dyspnea, hypoxia, may be counteracted; monitor laboratory parameters. bronchospasm, tachycardia, hypotension, cyanosis, vomiting, nausea, headache, sweating, dizziness, altered mentation, flushing, rash, urticaria, erythema, USE IN SPECIFIC POPULATIONS pyrexia, or chills. If a hypersensitivity reaction occurs, stop infusion of SMOFlipid • Pregnancy and Lactation: There are no available data on risks associated with immediately and undertake appropriate treatment and supportive measures. SMOFlipid when used in pregnant or lactating women. • Risk of Catheter-Related Infections: Lipid emulsions, such as SMOFlipid, can • Pediatric Use: The safety and effectiveness of SMOFlipid have not been support microbial growth and is an independent risk factor for the development established in pediatric patients. of catheter-related bloodstream infections. The risk of infection is increased in • Hepatic Impairment: Parenteral nutrition should be used with caution in patients patients with malnutrition-associated immunosuppression, long-term use and with hepatic impairment. Hepatobiliary disorders are known to develop in some poor maintenance of intravenous catheters, or immunosuppressive effects of patients without preexisting liver disease who receive PN, including cholestasis, other concomitant conditions or drugs. hepatic steatosis, fibrosis and cirrhosis (PN associated liver disease), possibly • Fat Overload Syndrome: This is a rare condition that has been reported with leading to hepatic failure. intravenous lipid emulsions. A reduced or limited ability to metabolize lipids accompanied by prolonged plasma clearance may result in a syndrome OVERDOSE characterized by a sudden deterioration in the patient’s condition including fever, In the event of an overdose, fat overload syndrome may occur. Stop the SMOFlipid anemia, leukopenia, thrombocytopenia, coagulation disorders, hyperlipidemia, infusion until triglyceride levels have normalized. The effects are usually reversible fatty liver infiltration (hepatomegaly), deteriorating liver function, and central by stopping the lipid infusion. If medically appropriate, further intervention may be nervous system manifestations (e.g., coma). indicated. Lipids are not dialyzable from serum. • Refeeding Syndrome: Reintroducing calories and protein to severely undernourished patients with PN may result in the refeeding syndrome, characterized by the intracellular shift of potassium, phosphorus, and magnesium as the patient becomes anabolic. Thiamine deficiency and fluid retention may also develop. • Aluminum Toxicity: SMOFlipid contains no more than 25 mcg/L of aluminum. During prolonged PN administration in patients with renal impairment, the 9,-,9,5*,:! Vanek VW, et al. A.S.P.E.N. position paper: Clinical role for alternative intravenous aluminum levels in the patient may reach toxic levels. Preterm infants are at fat emulsions. Nutr Clin Pract. 2012;27(2):150-192. Deckelbaum RJ, et al. Medium-chain versus greater risk because their kidneys are immature, and they require large amounts long-chain triacylglycerol emulsion hydrolysis by lipoprotein lipase and hepatic lipase: implications for of calcium and phosphate solutions, which contain aluminum. Patients with the mechanisms of lipase action. Biochemistry (Mosc). 1990;29(5):1136-1142. renal impairment, including preterm infants, who receive parenteral intakes of
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hospital encounter that I included in this study was related to a COPD or asthma visit,” she said. A lot of these patients were set up with primary care during the study period, which could be another factor contributing to the positive findings, she added. The median amount billed per patient decreased from $4,683 before PAP enrollment to $0 (P<0.001), and the median hospital acquisition cost per person dropped
Piedmont Athens PAP Successes: Cumulative ED visits decreased from 54 to seven Cumulative hospitalizations dropped from 13 to zero Median amount billed per patient decreased from $4,683 to $0 Median hospital acquisition cost per person dropped from $351 to $0
from $351 to $0 (P=0.002), according to the study (No. 5) presented at the American College of Clinical Pharmacy’s 2020 virtual poster symposium. “I knew there was a benefit for the patient; however, I wasn’t expecting to see that much of a monetary decrease as well as seeing ED visits decrease by almost 90% in these patients,” said Dr. Gallman, who added that a pharmacy buyer who is a certified pharmacy technician helps enroll patients in the PAP. “We were really happy with our results, and we think that it justifies continuing this program.”
Some Caveats It would have been helpful to see patient medication compliance information before and after participation in the program to confirm the validity of the conclusions and learn whether the PAP provided medications or coupons, commented Mark Malesker, PharmD, a professor of pharmacy practice at Creighton University, in Omaha, Neb., who works with pulmonary critical care patients. He noted that it’s also unusual to put asthma and COPD patients together in one study, he said, because those populations tend to have different demographics. —Karen Blum The sources reported no relevant financial relationships.
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