An Experiment to Convert Structured Product Labels into Computable Prescribing Information

2021 ◽  
Author(s):  
Allen Flynn ◽  
Charlie Huang ◽  
Natalie Lampa ◽  
George Meng ◽  
Nate Gittlen ◽  
...  
Keyword(s):  
Prescribing Information

Warning Added to Xigris Prescribing Information

2005 ◽  
Vol 38 (8) ◽  
pp. 59
Author(s):  
MICHELE G. SULLIVAN
Keyword(s):  
Prescribing Information

scholarly journals Phosphate Control: The Next Frontier in Dialysis Cardiovascular Mortality

2021 ◽  
pp. 1-10
Author(s):  
Peter A. McCullough
Keyword(s):  
Calcium Acetate ◽  
Paracellular Pathway ◽  
Ferric Citrate ◽  
Morbidity And Mortality ◽  
Phosphate Binders ◽  
Phosphate Absorption ◽  
Phosphate Retention ◽  
Sevelamer Carbonate ◽  
Prescribing Information ◽  
Phosphate Control

<b><i>Background:</i></b> Cardiovascular disease (CVD) is a major cause of death in patients with chronic kidney disease (CKD) on dialysis. Mortality rates are still unacceptably high even though they have fallen in the past 2 decades. Hyperphosphatemia (elevated serum phosphate levels) is seen in almost all patients with advanced CKD and is by far the largest remaining modifiable contributor to CKD mortality. <b><i>Summary:</i></b> Phosphate retention drives multiple physiological mechanisms linked to increased risk of CVD. Fibroblast growth factor 23 and parathyroid hormone (PTH) levels, both of which have been suggested to have direct pathogenic CV effects, increase in response to phosphate retention. Phosphate, calcium, and PTH levels are linked in a progressively worsening cycle. Maladaptive upregulation of phosphate absorption is also likely to occur further exacerbating hyperphosphatemia. Even higher phosphate levels within the normal range may be a risk factor for vascular calcification and, thus, CV morbidity and mortality. A greater degree of phosphate control is important to reduce the risk of CV morbidity and mortality. Improved phosphate control and regular monitoring of phosphate levels are guideline-recommended, established clinical practices. There are several challenges with the current phosphate management approaches in patients with CKD on dialysis. Dietary restriction of phosphate and thrice-weekly dialysis alone are insufficient/unreliable to reduce phosphate to &#x3c;5.5 mg/dL. Even with the addition of phosphate binders, the only pharmacological treatment currently indicated for hyperphosphatemia, the majority of patients are unable to achieve and maintain phosphate levels &#x3c;5.5 mg/dL (or more normal levels) [PhosLo® gelcaps (calcium acetate): 667 mg (prescribing information), 2011, VELPHORO®: (Sucroferric oxyhydroxide) (prescribing information), 2013, FOSRENAL®: (Lanthanum carbonate) (prescribing information), 2016, AURYXIA®: (Ferric citrate) tablets (prescribing information), 2017, RENVELA®: (Sevelamer carbonate) (prescribing information), 2020, RealWorld dynamix. Dialysis US: Spherix Global Insights, 2019]. Phosphate binders do not target the primary pathway of phosphate absorption (paracellular), have limited binding capacity, and bind nonspecifically [PhosLo® gelcaps (calcium acetate): 667 mg (prescribing information). 2013, VELPHORO®: (Sucroferric oxyhydroxide) (prescribing information), 2013, FOSRENAL®: (Lanthanum carbonate) (prescribing information), 2016, AURYXIA®: (Ferric citrate) tablets (prescribing information), 2017, RENVELA®: (Sevelamer carbonate) (prescribing information) 2020]. <b><i>Key Messages:</i></b> Despite current phosphate management strategies, most patients on dialysis are unable to consistently achieve target phosphate levels, indicating a need for therapeutic innovations [RealWorld dynamix. Dialysis US: Spherix Global Insights, 2019]. Given a growing evidence base that the dominant mechanism of phosphate absorption is the intestinal paracellular pathway, new therapies are investigating ways to reduce phosphate levels by blocking absorption through the paracellular pathway.

Canadian Marketing Codes: How Well are They Controlling Pharmaceutical Promotion?

1994 ◽  
Vol 24 (1) ◽  
pp. 91-104 ◽  
Author(s):  
Joel Lexchin
Keyword(s):  
Advisory Board ◽  
Regulatory Body ◽  
Pharmaceutical Advertising ◽  
Government Control ◽  
Promotional Material ◽  
Legislative Authority ◽  
Pharmaceutical Manufacturers ◽  
Pharmaceutical Promotion ◽  
Enforcement Mechanisms ◽  
Prescribing Information

Pharmaceutical promotion in Canada is controlled by two codes: a voluntary one developed by the Pharmaceutical Advertising Advisory Board dealing mostly with printed promotional material, and one from the Pharmaceutical Manufacturers Association of Canada covering other forms of promotion. This article looks at enforcement of the provisions of these codes and at areas in which they are deficient. One of the major weaknesses in both codes is their lack of effective sanctions for companies that violate their provisions. Strong codes are necessary because many physicians rely heavily on promotional material for their source of prescribing information. However, voluntary codes or codes developed by the industry are inherently weak and lack effective enforcement mechanisms. Although the U.S. Food and Drug Administration is currently very active in curtailing promotional excesses, government control is not the solution since regulatory action will depend on the ideological position of the head of the regulatory body and/or the party in power. An independent body backed by legislative authority is preferable.

Transdermal Patch Administration and Magnetic Resonance Imaging (MRI)—2020

2021 ◽  
pp. 001857872098713
Author(s):  
Janna Afanasjeva ◽  
Michael Gabay ◽  
Thomas Poznanski ◽  
Stefanie Kerns
Keyword(s):  
Magnetic Resonance Imaging ◽  
Magnetic Resonance ◽  
Drug Administration ◽  
Hospital Pharmacy ◽  
Transdermal Patch ◽  
Resonance Imaging ◽  
Mri Scan ◽  
Transdermal Patches ◽  
Magnetic Resonance Imaging Mri ◽  
Prescribing Information

This is an update to the 2010 article published in Hospital Pharmacy on safety concerns involving transdermal patches and magnetic resonance imaging (MRI). Since publication of the original article, new brand and generic transdermal medications have become available and notable changes regarding the presence or absence of metallic content among existing transdermal formulations occurred. To update the tables within the article, Food and Drug Administration (FDA)-approved transdermal medications through October 2020 were researched in order to determine metallic content and procedures for reapplication after MRI, if applicable. Readers should consult the prescribing information or manufacturer for the most current information on use of transdermal medications in the MRI setting. Of note, manufacturers have not evaluated the use of transdermal products while patients undergo a MRI scan.

#92: What Is the Optimal Management of Patients Immunosuppressed with the Anti-compliment Monoclonal Antibody, Eculizumab? A Case Report and Review

2021 ◽  
Vol 10 (Supplement_1) ◽  
pp. S12-S12
Author(s):  
I Tinoco ◽  
A Jarrell ◽  
L Correa ◽  
J Bissler ◽  
J DeVincenzo ◽  
...  
Keyword(s):  
Monoclonal Antibody ◽  
Renal Failure ◽  
Antibiotic Prophylaxis ◽  
Neisseria Meningitidis ◽  
Paroxysmal Nocturnal Hemoglobinuria ◽  
Neisseria Species ◽  
E Coli ◽  
Increased Risk ◽  
Prescribing Information ◽  
Rabbit Complement

Abstract Background Patients with deficiencies of terminal components of complement are at hundreds to thousands fold increased risk of severe and fatal Neisseria spp. infections compared with the general population. Eculizumab is a newly approved monoclonal antibody C5 complement inhibitor. It is indicated for the treatment of atypical hemolytic uremic syndrome (atypical HUS), myasthenia gravis, and paroxysmal nocturnal hemoglobinuria. Because of the complement-depleting effect of Eculizumab dosing (Soliris®, Alexion Pharmaceuticals, Munich, Germany), patients are immunosuppressed for specific infectious pathogens (including Neisseria species) against which protection partially relies on normal complement activity. Because Eculizumab treatment is associated with a dramatically increased risk of Neisseria species. infections, recommendations for Neisseria meningitidis vaccination and antibiotic prophylaxis are contained in Eculizumab prescribing information. However, the most appropriate prevention of infections after Eculizumab has yet to be determined. Methods Case report and literature review. Results A previously healthy 7-year-old male was diagnosed with atypical HUS which included renal failure progressing to dialysis, persistent thrombocytopenia, hemolytic anemia, and hemoglobinuria. Stool cultures and a stool multiplex PCR panel did not detect Shiga-like producing E. coli nor E. coli O157/H7. Eculizumab dosing was therefore planned and Infectious Diseases consultation was obtained for appropriate preventions. The FDA Prescribing Information recommends Neisseria meningitidis vaccination before starting Eculizumab or, if immediate Eculizumab is necessary, to use antibiotic prophylaxis until 2 weeks after vaccination. The accepted protective titer after meningococcal vaccination is population based and uses the serum bactericidal assay (SBA). An antibody titer of &gt;1:4 (human compliment) or 1:8 (rabbit complement) is considered protective. However, this “gold standard” assay incorporates the use of exogenous human or rabbit complement. The protective SBA titers in subjects with terminal complement component deficiencies may not be properly assessed using these same SBA titer protective thresholds. Furthermore, serious meningococcal infections have occurred after appropriate vaccination in patients receiving chronic Eculizumab treatments (ie for paroxysmal nocturnal hemoglobinuria). Finally, SBA protective levels after single Neisseria meningitidis vaccination have not been achieved in majorities of patients with renal failure receiving dialysis and or transplant immunosuppression. Conclusions The current Eculizumab prescribing information recommendations for vaccination and antimicrobial prophylaxis may be inadequate to prevent serious Neisseria infections. Repeated Neisseria meningitidis vaccination and extended antibiotic prophylaxis may afford better protection in patients chronically dosed with Eculizumab.

Maintenance of Goal Blood Pressure following Conversion from Lisinopril to Fosinopril

2003 ◽  
Vol 19 (5) ◽  
pp. 266-270
Author(s):  
Maqual R Graham ◽  
Nicole M Allcock ◽  
Cameron C Lindsey
Keyword(s):  
Blood Pressure ◽  
Goal Attainment ◽  
Prospective Observational Study ◽  
Goal Blood Pressure ◽  
Assessment Visit ◽  
Blood Pressures ◽  
Blood Pressure Goals ◽  
The Mean ◽  
Medical Histories ◽  
Prescribing Information

Objective: To determine whether blood pressure could be maintained for patients on lisinopril following conversion to a theorized, therapeutic dose of fosinopril. The tolerability of fosinopril was also assessed. Methods: Subjects receiving lisinopril were considered candidates for this prospective, observational study. Prescribing information for both lisinopril and fosinopril suggested a milligram-to-milligram equivalency. Patients taking lisinopril 10 mg/d were switched to fosinopril 10 mg/d. Blood pressures were compared at baseline and 2, 6, and 18 weeks after conversion. A goal blood pressure of <140/90 mm Hg was assigned to all patients at enrollment and used to determine goal attainment at baseline and 18 weeks. More aggressive blood pressure goals are currently recommended; thus, medical histories were reevaluated at the end of the study and new goals were assigned and assessed. Adverse effect occurrence was also compared between visits. Results: One hundred thirty-three subjects were enrolled. The mean dose of lisinopril prior to conversion was 15 ± 11 mg/d compared with the mean final fosinopril dose of 20 ± 14 mg/d. Both the mean systolic and diastolic blood pressures increased significantly at the 18-week visit when compared with baseline (p = 0.00007 and p = 0.015, respectively). Using a goal blood pressure of <140/90 mm Hg, there was no difference detected between the baseline and the final assessment visit (p = 0.851). A greater number of subjects were unable to achieve goal status at 18 weeks when compared with baseline after applying the newly defined goals (p = 0.003). Sixteen of the original 133 subjects discontinued fosinopril due to adverse events. Conclusions: When converting subjects from lisinopril to fosinopril, equivalent blood pressure may be difficult to achieve without increasing the dose of fosinopril.

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