October 2017 Newsletter
 
Webinar-  Thursday, November 9, 2017 - 12 noon-1:00 pm

Appropriate Hepatitis C Treatment options in Hep C/HIV Coinfections
 
Zuri C. Hawkins, PharmD
PGY2  Ambulatory Care Resident
Columbus Regional Health - Midtown Medical Center
 
Objectives:
 
¢  Review background and disease burden of Hepatitis C (Hep C or HCV) and HIV co-infected patients
¢  Identify pharmacologic treatment options for Hep C/ HIV co-infected patients
¢  Review current guideline recommendations for treating Hep C/HIV co-infected patients
¢  Review clinical utility of preferred regimens in Hep C/HIV co-infected patients
 
Georgia Society of Health-System Pharmacists is accredited by the Accreditation Council for Phar
macy Education (ACPE) as a provider of continuing pharmacy education. This program is approved for 1 hour (0.1 CEUs) of continuing pharmacy education credit.  Proof of participation will be posted to your NABP CPE profile within 4 to 6 weeks to participants who have successfully completed the post-test.   Participants must participate in the entire presentation and complete the course evaluation to receive continuing pharmacy education credit.  UAN  # 0228-0000-17-143-L01-P; 0228-0000-17-143-L01-T

This is a member service of GSHP.  There is no charge for members to attend.   Dues must be current to receive CE credit.
Non-members will be charged $20.


 
Webinar-Thursday, December 14, 2017 - 12 noon-1:00 pm
Clinical Case: Dual Calcium Channel Blockade for the Treatment of Hypertension 
 
 
AdrianStephens,PharmD
PGY2AmbulatoryCarePharmacyResident
GradyHealthSystem
 
Objectives: 

Recallcurrenttreatmentoptionsinthemanagementofresistanthypertension

Evaluatethemechanismsandpotentialsynergisticactivityofnondihydropyridine(Non-DHP)and dihydropyridine(DHP)calciumchannelblockers(CCBs)

  IdentifypatientpopulationswhichmaybenefitfromdualCCBtherapy
 
Georg ia  Society of Health-System Pharmacists is accredited by the Accreditation Council for Pharm acy Education (ACPE) as a provider of continuing pharmacy education. This program is approved for 1 hour (0.1 CEUs) of continuing pharmacy education credit.  Proof of participat ion will be posted to your NABP CPE profile within 4 to 6 weeks to 
participants who have successfully completed the post-test.   Participants must participate in the entire presentation and complete the course evaluation to receive continuing pharmacy education credit.  UAN  # 0228-0000-17-144-L01-P; 0228-0000-17-144-L01-T



This is a member service of GSHP.  There is no charge for members to attend.   Dues must be current to receive CE credit.
Non-members will be charged $20.

Non-member registration:  Email
sglass@gshp.org
Clinical Managers Call

Monthly Georgia Society of Health System Pharmacists invites all clinical leaders across the state to participate in a monthly conference call on current clinical pharmacy related topics affecting the practice of clinical pharmacy across the state.  Clinical Coordinators, Clinical Managers, Assistant Directors of Clinical Services or anyone else who serves in a formal or informal clinical leadership role is welcome to participate.  Calls are held at 3:00 PM the third Monday of every month. A call for agenda items will be sent out the week prior, and the final agenda will be sent out prior to the call.    

Clinical Articles

The Skinny on Weight Loss Drugs: The New Kids on the Block
Authors: Thomas 'Judd' Ott, Student Pharmacist Mercer University, Kendra Manigault, Pharm.D., BCPS, BCACP, CDE, Clinical Assistant Professor, Mercer University, Amy Grimsley, Pharm.D. BCOP, Pharmacy Residency Coordinator and Pharmacy Educator, Cheyenne Regional Medical Center


Introduction
Obesity increases the risk of comorbidities, decreases quality of life, and increases overall mortality rates. Of note, greater than 60 comorbidities are associated with obesity including cardiovascular diseases, diabetes, pulmonary issues, and several types of cancers. 1 , 2 Although patients seeking obesity treatment may be extremely overweight or obese, the expert panel of the 2013 American College of Cardiology/American Heart Association Task Force on Practice Guidelines and The Obesity Society (AHA/ACC/TOS) Obesity Guidelines report that a modest sustained weight loss of 3%-5% can provide clinically meaningful reductions in triglycerides, blood glucose, glycated hemoglobin (HbA1C), and risk of developing type 2 diabetes. Furthermore, slightly greater  weight loss (>5%) can lead to blood pressure reduction, improvement in low-density lipoprotein cholesterol (LDL-C) and high-density lipoprotein cholesterol (HDL-C), and reduction of medications. 3 Successful weight loss of 3%-5% can be achieved by non-pharmacological treatment but it may be difficult for most patients to continue the strict diets and regular exercise necessary to maintain their initial weight loss. 4   As a result, drug therapy can provide patients with additional reduction which can potentially have considerable health benefits. The purpose of this second article of a three-part series is to look at additional options for weight loss therapy and briefly discuss some of the additional benefits associated with sustained weight loss due to pharmacological treatment.

GLP-1 agonist

Liraglutide (Saxenda®)

Liraglutide approved for weight loss under the brand name Saxenda®, is an agonist of the human glucagon-like peptide -1 (GLP-1) receptor. It is designed to mimic the endogenous human GLP-1, a physiological regulator of appetite and caloric intake.  By mimicking this endogenous peptide sequence it activates the GLP-1 receptor leading to decreased body weight. 5
                Liraglutide is also marketed under the brand name Victoza® as treatment for type 2 diabetes; however, Saxenda® is not indicated for and should not be used for the management of type 2 diabetes. 5 Liraglutide should be used in combination with a reduced-calorie diet and increased physical activity for the long term weight management in patients with an initial BMI ≥ 30 kg/m 2 or ≥27 kg/m 2 accompanied with other risk factors (hypertension, diabetes, and dyslipidemia). 5 Liraglutide is available as an 18 mg/3 mL prefilled multi-dose pen used for subcutaneous injections.  Liraglutide should be initiated at 0.6 mg once daily at any time of the day without regards to meals. The dose should be increased in weekly intervals of 0.6 mg increments until a 3 mg per day dose is achieved at week five. If patients cannot tolerate the 3 mg dose or has not reached at least a 4% weight loss in a 16 week period, liraglutide should be discontinued. 5
                Clinical trials of liraglutide for weight loss confirmed liraglutide is significantly better than placebo in producing and maintaining weight loss. 6,7 A clinical trial of liraglutide 3 mg compared to placebo in weight management found that liraglutide resulted in greater weight loss than placebo. The liraglutide group achieved an average of 8.0±6.7% body weight lost and 63.2% of patients lost at least 5% of baseline body weight compared to an average of 2.6±5.7% of body weight lost and 27.1% of patients that lost at least 5% in the placebo group. 8 One clinical trial showed liraglutide 3 mg was responsible for a mean weight loss of 7.2 kg compared to 2.8 kg in placebo groups. A trial looking specifically at liraglutide's ability to maintain the lost weight showed patients lost an additional 6.2% of weight after obtaining a 5% weight loss from a low calorie diet (P < 0.0001), these patients not only lost additional weight but 81.4% were able to maintain the initial 5% weight loss compared to only 48.9% in the placebo group (P < 0.0001). 7
Liraglutide's most common adverse effects are typically dose related  and associated with nausea, vomiting, diarrhea, constipation, dyspepsia, and abdominal pain. 9 Liraglutide carries a black box warning for risk of thyroid C-cell tumors and is contraindicated in patients with a personal or family history of medullary thyroid carcinoma and in patients with Multiple Endocrine Neoplasia syndrome type 2.  As a result, patients should be monitored accordingly while receiving therapy. Cases of acute pancreatitis have been reported in postmarked clinical trials as well. There also were reports of acute renal failure but a causal relationship between liraglutide use and renal failure has not been established. 5

5-HT2C Receptor Agonist

Lorcaserin (Belviq®)

Lorcaserin, marketed as Belviq®, is approved for chronic weight management. It is a serotonin 2C (5-HT 2C) receptor agonist that possesses an unknown mechanism of action for weight loss. It is believed lorcaserin selectively activates 5-HT 2C receptors on anorexigenic pro-opiomelancortin neurons in the hypothalamus. These neurons are thought to decrease food consumption and promote a feeling of fullness, decreasing caloric intake. 10
Lorcaserin is indicated for chronic weight management in conjunction with diet and exercise in adults with BMI ≥ 30 kg/m 2 or ≥27 kg/m 2 accompanied with other risk factors (hypertension, diabetes, and dyslipidemia). It is available as a 10 mg tablet and should be administered twice a day with or without food. Patients should be evaluated at 12 weeks for efficacy; if 5% of baseline body weight has not been achieved therapy should be discontinued.
Lorcaserin trials have proven to be significantly more effective than placebo (P < 0.001) in trials reviewed for this article. 11,12 A 2010 study showed at the end of 1 year, lorcaserin provided patients with a mean average of 5.8 kg weight loss versus just 2.2 kg for placebo group; and 47.5% of patients received greater than 5% loss from baseline body weight versus 20.3% in the placebo group. 11 Participants were also evaluated after 2 years to determine maintenance of weight loss.  After the first year, patients who received placebo continued on placebo therapy while patients receiving lorcaserin continued lorcaserin or switched to placebo in a 2:1 ratio. Initial weight loss of ≥5% was maintained in 67.9% of the lorcaserin group compared to 50.3% in the placebo group  (P < 0.001). 11 The lorcaserin study group in the one year BLOSSOM trial showed similar results as 47.2% of lorcaserin treated patients achieved a 5% loss from baseline body weight compared to 25% in the placebo group (P < 0.001). The lorcaserin groups mean change from baseline was 5.8 kg vs 2.9 kg for the placebo group (P<0.001). 12
Clinical trial data identified the most common adverse reactions as headache, dizziness, fatigue, nausea, dry mouth, and constipation. 10 The risk of serotonin syndrome, a syndrome associated with all serotonergic drugs, is a potential concern with lorcaserin; therefore, an assessment of patients' medications for other serotonergic drugs should be completed to reduce this risk. 10 Other rare reactions that may occur includes cognitive impairment, psychiatric disorders, priapism, decreased heart rate, decreased white blood cell count, elevated prolactin levels, and pulmonary hypertension. 10

Discussion:

Reports supporting the reduced severity of several comorbidities with sustained weight loss of 3-5% support the use of drug therapy in patients needing assistance to achieve a healthier weight. Overweight patients present with comorbidities such as hypertension, diabetes, and dyslipidemia which complicates the patient's quest to lose weight. Fortunately, many of the weight loss drugs demonstrated the ability to help improve these comorbidities in select clinical trials. Liraglutide was shown to improve blood pressure, fasting plasma glucose levels, HbA 1c and decrease the number of study participants with prediabetes. 6,7 Lorcaserin has shown improvements in HbA 1c and fasting blood glucose. 11-13 Naltrexone/bupropion was shown to improve triglycerides and HDL levels. 14-16Orlistat, discussed in part 1 of this series, has been seen to provide improvements in total cholesterol and HDL levels for most patients. 17-20 Phentermine/topiramate, which will be discussed in part 3 of this series, showed improvements in systolic and diastolic blood pressure, glycemic parameters, and lipid panels. 21-23 Additionally, the SEQUEL trial showed phentermine/topiramate decreased the number of medications needed to manage hypertension, dyslipidemia, and glycemic control while patients on placebo required more medications to manage these conditions. 23
Regardless of the benefits of these drugs they are not without potential side effects. Comorbid conditions should be considered to decrease the potential for unwanted effects. For example, sympathomimetic amines would not be the drug of choice in patients at high risk for cardiovascular events. Of note, phentermine has not been shown to adversely affect blood pressure and heart rate, but more clinical observation is needed in this area. 24  In patients with higher baseline heart rates, it may be best to avoid the combination of phentermine/topiramate since its use has been linked to increases in heartrate of 20 beats per minute. Liraglutide may be a good choice for patients with diabetes, although not recommended to be used for glycemic control, since it has been shown to have favorable effects on HbA 1c  and fasting blood glucose levels while providing weight loss. 8  Patients on serotonergic drugs should possibly avoid lorcaserin due to the risk of serotonin syndrome. Physicians and other healthcare providers should do their due diligence in assessing the patient for potential disease state and drug contraindications.

Conclusion:
Comparison trials are needed to comprehensively evaluate the varying benefit of weight loss agents. Providers should evaluate the risk versus benefit of these medications when determining the best options for patients.
   
1.         Guh DP, Zhang W, Bansback N, Amarsi Z, Birmingham CL, Anis AH. The incidence of co-morbidities related to obesity and overweight: A systematic review and meta-analysis. BMC Public Health. 2009;9:88. doi:10.1186/1471-2458-9-88.
2.         Hurt RT, Edakkanambeth Varayil J, Ebbert JO. New pharmacological treatments for the management of obesity. Curr Gastroenterol Rep. 2014;16(6):394. doi:10.1007/s11894-014-0394-0.
3.         Bonow RO, Carabello BA, Chatterjee K, et al. 2013 AHA/ACC/TOS Guideline for the management of overweight and obesity in adults. Circulation. 2008;118:e523-e661.
4.         Obesity NAA for the S of, Heart N, Institute B, (US) NI of H, Initiative NOE. The Practical Guide: Identification, Evaluation, and Treatment of Overweight and Obesity in Adults. National Institutes of Health, National Heart, Lung, and Blood Institute, NHLBI Obesity Education Initiative, North American Association for the Study of Obesity; 2000.
5.         liraglutide - saxenda drug information. http://dailymed.nlm.nih.gov/dailymed/getFile.cfm?setid=3946d389-0926-4f77-a708-0acb8153b143&type=pdf&name=3946d389-0926-4f77-a708-0acb8153b143. Accessed June 3, 2015.
6.         Astrup A, Rössner S, Van Gaal L, et al. Effects of liraglutide in the treatment of obesity: a randomised, double-blind, placebo-controlled study. The Lancet. 2009;374(9701):1606-1616.
7.         Wadden TA, Hollander P, Klein S, et al. Weight maintenance and additional weight loss with liraglutide after low-calorie-diet-induced weight loss: The SCALE Maintenance randomized study. Int J Obes. 2013;37(11):1443-1451. doi:10.1038/ijo.2013.120.
8.         Pi-Sunyer X, Astrup A, Fujioka K, et al. A Randomized, Controlled Trial of 3.0 mg of Liraglutide in Weight Management. N Engl J Med. 2015;373(1):11-22. doi:10.1056/NEJMoa1411892.
9.         Fujioka K. Safety and tolerability of medications approved for chronic weight management. Obesity. 2015;23:S7-S11. doi:10.1002/oby.21094.
10.       Lorcaserin - Belviq drug information. http://dailymed.nlm.nih.gov/dailymed/getFile.cfm?setid=7cbbb12f-760d-487d-b789-ae2d52a3e01f&type=pdf&name=7cbbb12f-760d-487d-b789-ae2d52a3e01f. Accessed June 3, 2015.
11.       Smith SR, Weissman NJ, Anderson CM, et al. Multicenter, placebo-controlled trial of lorcaserin for weight management. N Engl J Med. 2010;363(3):245-256.
12.       Fidler MC, Sanchez M, Raether B, et al. A One-Year Randomized Trial of Lorcaserin for Weight Loss in Obese and Overweight Adults: The BLOSSOM Trial. J Clin Endocrinol Metab. 2011;96(10):3067-3077. doi:10.1210/jc.2011-1256.
13.       O'Neil PM, Smith SR, Weissman NJ, et al. Randomized Placebo-Controlled Clinical Trial of Lorcaserin for Weight Loss in Type 2 Diabetes Mellitus: The BLOOM-DM Study. Obesity. 2012;20(7):1426-1436. doi:10.1038/oby.2012.66.
14.       Effect of naltrexone plus bupropion on weight loss in overweight and obese adults (COR-I): a multicentre, randomized, double-blind, placebo-controlled, phase 3 trial. https://d1niluoi1dd30v.cloudfront.net/01406736/S0140673610X61438/S0140673610608884/main.pdf?Expires=1433432434&Key-Pair-Id=APKAICLNFGBCWWYGVIZQ&response-content-disposition=attachment%3Bfilename%3D%22download.pdf%22&Signature=AirhveFbYAr06KfwcPbrzXH2AAl20U8N1ml0sh%7ESB4-1rC%7Ea%7ERlD-dUP77yjl4DxLwUmOQfqJYaDle3c72TYYz8CaOHGL1u-3L1td5NZ3u5OrVpMEkl1OOKZw7A1AsO%7ENITte0RXO3aPL%7EBAg5-QE1Cx%7E3fTCf%7EwvOFdJRPRycY_. Accessed June 4, 2015.
15.       Wadden TA, Foreyt JP, Foster GD, et al. Weight Loss With Naltrexone SR/Bupropion SR Combination Therapy as an Adjunct to Behavior Modification: The COR-BMOD Trial. Obesity. 2011;19(1):110-120. doi:10.1038/oby.2010.147.
16.       Apovian CM, Aronne L, Rubino D, et al. A randomized, phase 3 trial of naltrexone SR/bupropion SR on weight and obesity-related risk factors (COR-II). Obesity. 2013;21(5):935-943. doi:10.1002/oby.20309.
17.       One-year treatment of obesity: a randomized, double-blind, placebo-controlled, multicentre study of orlistat, a gastrointestinal lipase inhibitor. 2000;24(3). doi:10.1038/sj.ijo.0801128.
18.       Hill JO, Hauptman J, Anderson JW, et al. Orlistat, a lipase inhibitor, for weight maintenance after conventional dieting: a 1-y study. Am J Clin Nutr. 1999;69(6):1108-1116.
19.       Rössner S, Sjöström L, Noack R, Meinders A, Noseda G. Weight loss, weight maintenance, and improved cardiovascular risk factors after 2 years treatment with orlistat for obesity. Obes Res. 2000;8(1):49-61.
20.       Krempf M, Louvet J-P, Allanic H, Miloradovich T, Joubert J-M, Attali J-R. Weight reduction and long-term maintenance after 18 months treatment with orlistat for obesity. Int J Obes. 2003;27(5):591-597. doi:10.1038/sj.ijo.0802281.
21.       Allison DB, Gadde KM, Garvey WT, et al. Controlled-Release Phentermine/Topiramate in Severely Obese Adults: A Randomized Controlled Trial (EQUIP). Obesity. 2012;20(2):330-342. doi:10.1038/oby.2011.330.
22.       Gadde KM, Allison DB, Ryan DH, et al. Effects of low-dose, controlled-release, phentermine plus topiramate combination on weight and associated comorbidities in overweight and obese adults (CONQUER): a randomised, placebo-controlled, phase 3 trial. The Lancet. 2011;377(9774):1341-1352.
23.       Garvey WT, Ryan DH, Look M, et al. Two-year sustained weight loss and metabolic benefits with controlled-release phentermine/topiramate in obese and overweight adults (SEQUEL): a randomized, placebo-controlled, phase 3 extension study. Am J Clin Nutr. 2012;95(2):297-308. doi:10.3945/ajcn.111.024927.
24.       Hendricks EJ, Greenway FL, Westman EC, Gupta AK. Blood Pressure and Heart Rate Effects, Weight Loss and Maintenance During Long-Term Phentermine Pharmacotherapy for Obesity. Obesity. 2011;19(12):2351-2360. doi:10.1038/oby.2011.94.
 
Delafloxacin (Baxdela™)
 
Authors: Brett A. Eisenmann, Pharm.D. Candidate 20181, Daniel B. Chastain Pharm.D., AAHIVP1,2
University of Georgia College of Pharmacy1 and Phoebe Putney Memorial Hospital2, Albany, Georgia
 
Delafloxacin (DLX) is a novel fluoroquinolone (FQ) antibiotic recently approved by the Food and Drug Administration (FDA) for the treatment of acute bacterial skin and skin structure infections (ABSSSI).1  It has bactericidal activity via the same mechanism of action as other FQs through inhibition of DNA gyrase and topoisomerase.2,3  DLX provides coverage against Gram-positive and Gram-negative organisms, including both methicillin susceptible Staphylococcus aureus (MSSA) and methicillin resistant S. aureus (MRSA), Enterobacteriaceae, and Pseudomonas aeruginosa (table 1).  Due to its broad spectrum of activity, DLX has the potential to become another big weapon against multi-drug resistant organisms.
 
The recommended dose for DLX is 450 mg orally every 12 hours and 300 mg intravenously every 12 hours.1  DLX has an oral bioavailability of 58% and a large volume of distribution (35 L).  It is primarily eliminated through the kidneys (65%) as unchanged drug.  Of note, dosing adjustments are based on estimated glomerular filtrate rate (eGFR), but are not required for oral formulations.  The dose of intravenous DLX should be decreased to 200 mg every 12 hours for patients with eGFR 15-29 mL/min/1.73m2.  Additionally, intravenous DLX should be discontinued in patients with eGFR < 15 mL/min/1.73m2 or in those receiving hemodialysis to avoid accumulation of the intravenous vehicle, sulfobutylether-β-cyclodextrin.  DLX is well tolerated, with the most common side effects including nausea, vomiting, diarrhea, headache, and transaminitis.  Similar to other FQs, DLX may cause serious adverse reactions, including tendinitis, tendon rupture, peripheral neuropathy, central nervous system effects, myasthenia gravis exacerbations, and Clostridium difficile-associated diarrhea.  Alternatively, DLX does not affect cardiac repolarization (QT/QTc prolongation).
 
DLX has completed two randomized, multicenter, multinational, double-blind, double-dummy, non-inferiority phase 3 trials in a total of 1,510 adults for treatment of ABSSSIs.1 The first trial studied a 300 mg intravenous dose of DLX given every 12 hours while the second trial gave 300 mg DLX intravenously every 12 hours for 6 doses, and then switched to 450 mg orally every 12 hours.  Each trial compared DLX against vancomycin 15 mg/kg (actual body weight) plus aztreonam for 5 to 14 days.  Aztreonam could be discontinued in the absence of Gram-negative pathogens.  Success was defined as an objective response at 48-72 hours, based on > 20% decrease in lesion size with no additional antibiotics needed, major procedures, or death in the intent-to-treat (ITT) population.  Similar success rates were identified in trials 1 and 2 between DLX and vancomycin/aztreonam (78.2% vs. 80.9%, and 83.7% and 80.6%, respectively).  In each of these trials, DLX was statistically non-inferior to vancomycin/aztreonam.  Additionally, the FDA designated DLX as designated as a Qualified Infectious Disease Product (QIDP) for the specific indications of ABSSSI and community acquired bacterial pneumonia (CABP).4  Currently, DLX is not FDA approved for CABP, but is undergoing phase 3 clinical trials.
 
Due to modifications in the chemical structure, DLX is anionic at physiological pH, unique from other FQs, which are found in their zwitterionic form.2-4  As a result, DLX is able to retain potency in acidic environments potentially achieving higher concentrations in bacterial cells.  This may be advantageous against organisms such as S. aureus, which have a high tolerance of survival in acidic media, such as an abscess or empyema.2   Importantly, S. aureus, especially MRSA, can quickly develop on therapy resistance to FQs despite in vitro susceptibility.5-7  DLX also exhibits activity against both pneumococcal and atypical bacteria.1  Due to the numerous options for ABSSSI and CABP, additional clinical studies are needed to identify DLXs optimal place in therapy.
 
Table 1.  In vitro activity among fluoroquionolones.8
 
 
DLX
CIPRO
LEVO
MOXI
Gram-positive aerobes
×     Enterococcus faecalis
×     Enterococcus faecium
×     Staphylococcus aureus (MSSA and MRSA)
×     Streptococcus pneumoniae
 
+
+
+*
 
+
 
±
-
±*
 
-
 
+
-
±*
 
+
 
+
±
±*
 
+
Gram-negative aerobes
×     Enterobacteriaceae
×     Haemophilus influenzae
×     Moraxella catarrhalis
×     Pseudomonas aeruginosa
 
+
+
+
+
 
+
+
+
+
 
+
+
+
+
 
+
+
+
-
Anaerobes
×     Clostridium difficile
×     Clostridium perfringens
×     Bacteroides fragilis
 
+
+
+
 
-
-
-
 
-
-
-
 
-
-
±
Atypical organisms
×     Legionella sp.
×     Mycoplasma pneumoniae
×     Chlamydophilia pneumoniae
 
+
+
+
 
+
+
+
 
+
+
+
 
+
+
+
DLX , delafloxacin (Baxdela™); CIPRO, ciprofloxacin (Cipro®); LEVO, levofloxacin (Levaquin®); MOXI, moxifloxacin (Avelox®)
[+],active in vitro; [-], not active in vitro; [±], variable activity in vitro
* On therapy resistance to FQs may develop in S. aureus, especially MRSA, despite in vitro susceptibility.5-7 
 
References:
  1. Baxdela (delafloxacin) package insert. Lincolnshire, IL: Melinta Therapeutics, Inc.; June 2017.
  2. Candel F, Penuelas M. Delafloxacin: design, development and potential place in therapy. Dovepress: Drug Design, Development and Therapy 2017:11 881-891.
  3.  Bambeke F. Delafloxacin, a non-zwitterionic fluoroquinolone in Phase III of clinical development: evaluation of its pharmacology, pharmacokinetics, pharmacodynamics and clinical efficacy. Future Microbiol. 2015;10(7): 1111-1123.
  4.  Kocsis B, Domokos J, Szabo D. Chemical structure and pharmacokinetics of novel quinolone agents represented by avarofloxacin, delafloxacin, finafloxacin, zabofloxacin and nemonoxacin. Ann Clin Microbiol Antimicrob. 2016;15(1):34.
  5.  Peterson LR, Quick JN, Jensen B, et al. Emergence of ciprofloxacin resistance in nosocomial methicillin-resistant Staphylococcus aureus isolates. Resistance during ciprofloxacin plus rifampin therapy for methicillin-resistant S aureus colonization. Arch Intern Med 1990;150:2151-5.
  6.  Blumberg HM, Rimland D, Carroll DJ, Terry P, Wachsmuth IK. Rapid development of ciprofloxacin resistance in methicillin-susceptible and -resistant Staphylococcus aureus. J Infect Dis 1991;163:1279-85.
  7.  Hooper DC. Emerging mechanisms of fluoroquinolone resistance. Emerg Infect Dis 2001;7(2):337-41.
  8.  Gilbert DN, et al. Sanford Guide to Antimicrobial Therapy 2017. 47th edition. Sperryville, VA, USA: Antimicrobial Therapy, Inc., 2017.

USP Chapter <800> Update

USP has announced the  intent to postpone  the official date of General Chapter <800> Hazardous Drugs - Handling in Healthcare Settings. In order to align with the next revision of General Chapter <797> Pharmaceutical Compounding - Sterile Preparations, to provide a unified approach to quality compounding. The next revision to General Chapter <797> is anticipated to be published in the Pharmacopeial Forum 44(5) September/October 2018 for a second round of public comment. Both USP General Chapter <797> and USP General Chapter <800> are anticipated to become official on December 1, 2019. Sections of the revised <797> may have longer implementation dates that will allow time for adoption of the standard.



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