Category Archives: Pharmaceuticals

The C Diff Foundation Welcomes Keith Nguyen, PharmD, BCPS, BCCCP

The C Diff Foundation Welcomes
Keith Nguyen, PharmD, BCPS, BCCCP to the  Foundation’s Antimicrobial Stewardship and CDI Prevention (ASCP) Committee

 

Keith Nguyen, PharmD, BCPS, BCCCP attended University of Illinois College of Pharmacy in Chicago, Illinois, where he is completed his doctorate program. From that point, Keith saw his niche in the hospital setting and went on to work at Edward-Elmhurst Healthcare.

At Edward-Elmhurst, Keith has moved into the primary role of the cardiac/neuro ICU pharmacist in which he practices hand and hand with various levels of providers. Keith has specialized himself in critical care, and has done various research projects into a variety of neuro and cardiac disorders. Throughout his years of practice, Keith has seen and provided care for various infectious diseases along with taking an integrate part in many Cdiff prevention programs.

Keith has presented at multiple critical care conferences and is a member of the Society of Critical Care Medicine, American Society of Health System Pharmacists (ASHP), along with the American Pharmacists Association.

Antimicrobial Stewardship and CDI Prevention (ASCP) Committee
Chair; Nick VanHise, PharmD, BCPS
Weiyan Feng, PharmD, RP
Allyssa M. Anderson, PharmD
Keith Nguyen, PharmD, BCPS, BCCCP

 

The C Diff Foundation Welcomes Allyssa Anderson, PharmD

The C Diff Foundation Welcomes Alyssa Anderson, PharmD to the Foundation’s Antimicrobial Stewardship and CDI Prevention (ASCP) Committee

 

Allyssa Anderson, PharmD attended Purdue University in West Lafayette, IN, where she completed their Pre-Pharmacy program and Doctor of Pharmacy program in a total of 6 years.

As a recent graduate, Allyssa will be completing a PGY-1 residency at Presence Saint Joseph’s Medical Center, which is part of the Presence/Amita Healthcare system. Allyssa aspires to pursue a career in infectious disease pharmacy after her residency program either as a provider or furthering her education with a second year of residency. Throughout her clinical experiences, Allyssa has taken part in several scientific research projects in the area of infectious diseases including, but not limited to, acute osteomyelitis, chronic osteomyelitis, clostridium difficile prophylaxis and prevention, and resistance trends.

In addition, Allyssa is a member of the American Society of Health System Pharmacists (ASHP), along with the American Pharmacists Association.

Antimicrobial Stewardship and CDI Prevention (ASCP) Committee
Chair; Nick VanHise, PharmD, BCPS
Weiyan Feng, PharmD, RP
Allyssa M. Anderson, PharmD
Keith Nguyen, PharmD, BCPS, BCCCP

C Diff Foundation ‘Making a Difference’ Award Presented to CutisPharma Inc.

The C Diff Foundation today announced that it presented CutisPharma, Inc., its “Making a Difference” award as a special recognition of the significant contribution that CutisPharma has made to the C.diff. Community: helping the advancement of C.diff. awareness as well as expanding treatment options for C.diff. patients.

C Diff Foundation

C Diff Foundation’s ‘Making a Difference’ Award Presented at CutisPharma’s Pre-Launch Celebration for Newly Approved C.diff. Drug FIRVANQ

(NEW PORT RICHEY, Fla.) — NEWS: The C Diff Foundation announced today that it presented CutisPharma, Inc., its “Making a Difference” award as a special recognition of the significant contribution that CutisPharma has made to the C.diff. Community: helping the advancement of C.diff. awareness as well as expanding treatment options for C.diff. patients.

The award was presented at CutisPharma’s celebration of its upcoming launch of FIRVANQ(TM), recently approved by the FDA for the treatment of Clostridium difficile associated diarrhea and enterocolitis caused by Staphylococcus aureus, including methicillin-resistant strains. Upon launch, FIRVANQ(TM) will be the only FDA-approved oral vancomycin solution treatment commercially available, improving patient access and reducing pharmacist burden by no longer having to compound oral liquid formulations.

“CutisPharma has been a committed partner of our Foundation and has furthered our mission to increase C.diff. awareness and support the research and development of new treatment options,” said Nancy C. Caralla, Foundress and Executive Director of the C Diff Foundation. “In recognition of CutisPharma’s efforts, we are pleased to grant them the ‘Making a Difference’ award at this special moment in the Company’s 20th anniversary year.”

“We are very grateful to receive such a special distinction from the C Diff Foundation,” said Neal I. Muni, MD, MSPH, and Chief Executive Officer of CutisPharma. “For 20 years, we have been committed to improving the lives of patients who are not well-served by existing therapies and would benefit from high-quality, cost-effective new treatment options. We greatly value our partnership with the C Diff Foundation and look forward to continuing to support their mission.”

In the USA: Nearly half a million Americans suffer from Clostridium difficile (C. diff.) infections in a single year according to a study released in 2015 by the Centers for Disease Control and Prevention (CDC). Approximately 29,000 patients died within 30 days of the initial diagnosis of C. difficile. Of those, about 15,000 deaths were estimated to be directly attributable to C. difficile infections making C. difficile a very important cause of infectious disease death in the United States.

About the C Diff Foundation:

The C Diff Foundation, a 501(c)(3)non-profit organization, established in 2012, is comprised of 100 percent volunteering professionals dedicated to supporting public health initiatives for C. difficile infection prevention, treatments, environmental safety, and support worldwide. For more information, visit: https://cdifffoundation.org/.

About CutisPharma:

CutisPharma, Inc., based in Wilmington, Mass., is privately held, specialty pharmaceutical company that has been the industry leader for 20 years in providing innovative solutions to pharmacists. CutisPharma’s FIRST(r) Unit-of-Use Compounding Kits have benefited millions of patients who are unable to swallow conventional oral dosage forms such as tablets and capsules and whose needs are not served by commercially available therapies. The Company’s first FDA-approved Kit, FIRVANQ(TM), will allow significantly broader patient access, convenience to pharmacists and patients alike by reducing the need for compounding, and serve as a potential cost-saving option to existing treatments. For more information, visit: https://cutispharma.com/.

 

Source:   https://enewschannels.com/c-diff-foundation-making-a-difference-award-presented-to-cutispharma-inc/

CutisPharma Announces FDA Approval Of FIRVANQ™ (vancomycin hydrochloride) for Oral Solution for Treatment of Clostridium difficile Associated Diarrhea (CDAD) and Staphylococcus aureus Colitis

CutisPharma Announces FDA Approval Of FIRVANQ™ For Treatment Of  Clostridium Difficile Associated Diarrhea (CDAD) And Staphylococcus Aureus Colitis

 

FDA-approved vancomycin oral liquid therapy expected to improve patient access and reduce pharmacist  burden by no longer having to compound liquid formulations

CutisPharma announced today, January 29, 2018,  that the US Food and Drug Administration (FDA) has approved FIRVANQ™ (vancomycin hydrochloride) for oral solution, for the treatment of Clostridium difficile associated diarrhea and enterocolitis caused by Staphylococcus aureus, including methicillin-resistant strains.

“We are pleased to announce the FDA approval of FIRVANQ,” said Neal I. Muni, MD, MSPH, Chief Executive Officer of CutisPharma. “FIRVANQ’s approval is an important step forward to providing patients the only FDA-approved vancomycin oral liquid treatment option for Clostridium difficile associated diarrhea, a life-threatening condition that affects over a half-million patients in the United States annually.”

Upon its launch, which is targeted to be April 2, 2018, FIRVANQ™ will replace CutisPharma’s FIRST®-Vancomycin Unit-of-Use Compounding Kit, which has been available to pharmacists that need a convenient, accurate, and compliant way to compound vancomycin oral liquid therapy. FIRVANQ™ will be commercially available in 25 mg/mL and 50 mg/mL strengths in convenient 150 mL and 300 mL sizes.  FIRVANQ™ is designed to be easy to use and has the potential to be a cost-effective alternative to existing vancomycin therapies.

“As a practicing infectious disease physician treating many patients with CDAD, having an FDA-approved vancomycin oral liquid formulation that is affordable and accessible to my patients is very beneficial,” said Stuart Johnson, MD, Loyola University Medical Center. “Patient access is currently limited by the fact that only a select few pharmacies perform compounding in the outpatient setting these days, given the many new regulations in place.  Availability of an FDA-approved vancomycin oral liquid treatment will effectively allow any pharmacy to stock this therapy, and hopefully encourage third-party payer reimbursement, significantly improving accessibility and convenience for patients.”

About CutisPharma

CutisPharma, Inc., based in Wilmington, Mass., is a privately held, specialty pharmaceutical company that has been the industry leader for 20 years in providing innovative solutions to pharmacists.  CutisPharma’s FIRST® Unit-of-Use Compounding Kits have benefited millions of patients who are unable to swallow conventional oral dosage forms such as tablets and capsules and whose needs are not served by commercially available therapies. The Company’s first FDA-approved Kit will allow significantly broader patient access, convenience to pharmacists and patients alike by reducing the need for compounding, and serve as a potential cost-saving option to existing treatments.  For more information, visit www.cutispharma.com

CutisPharma Partners With C Diff Foundation To Support C.difficile Infection Awareness and Advocacy Efforts

 

CutisPharma and the C Diff Foundation announced the launch of a partnership beginning on November 1, 2017, the first day of Clostridium difficile awareness month.  As part of the partnership, CutisPharma awarded an unrestricted grant to the Foundation to further support its awareness efforts.

“We are pleased to partner with the C Diff Foundation and support its education and advocacy efforts benefiting patients impacted by Clostridium difficile Infection,” said Neal I. Muni, MD, MSPH, Chief Executive Officer of CutisPharma.  “It’s our hope that our work together can make positive strides in building awareness of this life-threatening condition that affects over a half-million patients in the United States annually.”

The nonprofit C Diff Foundation is dedicated to supporting global public health initiatives for Clostridium difficile Infection (CDI), also called C. difficile or C. diff – for infection prevention, treatments and environmental safety.

“We are very thankful for CutisPharma’s support of our foundation’s efforts,” said Nancy Caralla, Foundress and Executive Director of the C Diff Foundation, who is both a nurse and a three-time C. difficile survivor who also lost her father to a C. difficile infection.  “CutisPharma’s mission to improve the lives of patients with unmet medical needs is aligned with our foundation’s goals, and we look forward to partnering with Neal and his team to further our education and advocacy efforts on behalf of patients and survivors.”

CutisPharma has undertaken several initiatives to expand from its traditional base of making compounding kits for pharmacists, including the development and commercialization of FDA-approved drugs. The filing of the Company’s first FDA New Drug Application earlier this year, by its RM Therapeutics subsidiary, was a key milestone in the Company’s expansion goals.

About CutisPharma

CutisPharma, Inc., based in Wilmington, Mass., is a privately held, specialty pharmaceutical company that has historically developed and distributed kits used by pharmacists to safely create compounded medications for nearly 20 years.  The Company’s products include oral solutions and suspensions, such as antimicrobials, mouthwashes, and PPIs; topicals, including hydrocortisone; and suppositories, including progesterone VGS.  CutisPharma’s FIRST Unit-of-Use Kits have benefited millions of patients who are unable to swallow conventional oral dosage forms such as tablets and capsules and whose needs are not served by commercially available therapies.  For more information, visit www.cutispharma.com.

Researchers From Loyola Medicine Retrospectively Studied 100 Vancomycin Taper and Pulse Treatment Patients Treated For Recurrent C. difficile Infection

A tapered and pulsed regimen with vancomycin — with diligent follow-up — can achieve significant cure rates in recurrent Clostridium difficile (C. difficile) infected patients, according to a new study.

Researchers from Loyola Medicine retrospectively studied 100 vancomycin taper and pulse treatment patients treated for recurrent C. difficile infection between January 1, 2009 and December 31, 2014. Their clinic, the study authors wrote, has been a referral center for the infection for the past decade.

To read the article in its entirety please click on the following link:

http://www.mdmag.com/medical-news/pulsed-and-tapered-vancomycin-likely-route-to-recurrent-clostridium-difficile-cure

However, despite the guidelines for treatment of recurrent C. difficile infection being not too different than recurrent episodes – except for the use of vancomycin when the case is severe – there have not been many studies on this vancomycin taper and pulsed dosing. 

The researchers observed that after a referral, the confirmed recurrent C. difficile patients were treated with a vancomycin taper and pulse regimen: a taper of vancomycin to once-daily, followed by alternate day dosing; or once-daily followed by alternate day dosing; followed by every third day, for at least 2 weeks. After this regimen, all patients had 90-day follow-up documentation.

On average, the patients in the clinic were on their third C. difficile diarrhea episode. Half of the patients had also received a standard course of vancomycin, while another third had received some type of vancomycin taper regimen, the researchers said.

Despite the fact that many of these patients were a “treatment experienced” population, 75% of the patients who received a supervised vancomycin taper and pulsed regimen achieved a cure,  study author Stuart Johnson  MD, . He added that the results were further improved for patients who received the expended pulse phase: 81% achieved a cure.

“The findings were not unexpected to us, but I think that many clinicians will be surprised how well a deliberate, prolonged vancomycin taper and pulse regimen – with careful follow up – works,” Johnson said.

There were no significant differences among the patients in terms of gender, age, concomitant antibiotics, proton pump inhibitor use, histamine receptor-2 blocker use, or patients with a regimen greater than 10 weeks in length, the researchers continued.

The researchers added that their finding of improved cure rates with alternate-day dosing plus every third day dosing over strictly alternate-day dosing is consistent with the hypothesis that pulsed dosing can promote a cyclical decrease in spore burden, they wrote. This can also permit the resetting of normal microbiota in the gut.

Johnson concluded that the clinical implications of the study show most recurrent C. difficile patients do not need fecal microbiota transplant (FMT).

“FMT has received an enormous amount of press and this procedure is now widely available throughout the US,” Johnson said. “FMT is attractive because it addresses one of the primary mechanisms involved with recurrent C. difficile infection, a marked disruption of the resident bacteria that populate the intestine and provide an important host defense against C. difficile.

Although physicians screen donor feces for “known pathogens,” not all is known of the potential complications to come from FMT, Johnson said.

“In addition, it appears that efficacy with a carefully supervised vancomycin taper and pulse regimen compare to that achieved with FMT,” Johnson said.

The study, “Vancomycin Taper and Pulsed Regimen with careful Follow up for Patients with Recurrent Clostridium difficile Infection,” was published in the journal Clinical Infectious Diseases.

Super-bugs Capture Attention As A Worldwide Health Threat

About 2 million Americans catch drug-resistant infections each year, and 23,000 die, according to the CDC.

As superbugs capture attention as a worldwide health threat, Washington University will be part of a national campaign against drug-resistant bacteria with a $2 million federal grant. The Centers for Disease Control and Prevention awarded $14 million to 25 medical schools and other organizations for research into how microorganisms in the body, known as the microbiome, can track and prevent infections by outsider, drug-resistant germs.

“Understanding the role the microbiome plays in antibiotic-resistant infections is necessary to protect the public’s health,” Dr. Tom Frieden, CDC director, said in a statement. “We think it is key to innovative approaches to combat antibiotic resistance, protect patients, and improve antibiotic use.”

The microbiome includes “good” bacteria and other beneficial organisms that live in the skin and in the digestive and respiratory tracts. Antibiotics that are supposed to fight “bad” bacteria can disrupt the natural habitat by unbalancing the good and bad. Then drug-resistant bacteria can take over and create an environment for out-of-control bugs, including methicillin-resistant staphylococcus aureus (MRSA), carbapenem-resistant enterobacteriaceae (CRE) and clostridium difficile (C. diff.).

Overexposure to antibiotics has been blamed for the rise in superbugs, with the CDC estimating that one in three antibiotic prescriptions is unnecessary.

The research project will look at how early exposure to antibiotics affects the development of the microbiome and whether there are better ways to protect the microbiome.

Four teams of researchers at Washington University were named to the local project:

  • Dr. Jeffrey Henderson will lead a team working to identify how diet and metabolism interact with the gut microbiome in a study to combat C. diff. intestinal infections.
  • A team led by Gautam Dantas will study the long-term effects of antibiotic therapy in premature infants and how their digestive microbiomes are affected.
  • Dr. Jennie Kwon will study antibiotics and the microbiome as it relates to pneumonia.
  • Dr. Brian Gage will help look at hemorrhages linked to the use of blood thinners.

The United Nations General Assembly focused on superbugs — in a rare discussion of health issues. The meeting comes after a new superbug resistant to last-resort antibiotics infected a Pennsylvania woman over the summer, and a resistant strain of E. coli was recently found in a 2-year-old Connecticut girl.

The CDC recommends increased testing for the superbug gene among certain types of E. coli bacteria that show resistance to the powerful antibiotic colistin. The gene spreads readily among bacteria, and it could make these multi-drug-resistant strains almost impossible to treat.

A cluster of gonorrhea infections in Hawaii has shown resistance to all treatments. Doctors are increasingly worried that the common sexually transmitted disease is gaining strength as one of the most urgent superbug threats. If untreated, the disease can lead to infertility.

To read article in its entirety click on the following link:

http://www.stltoday.com/lifestyles/health-med-fit/health/antibiotic-resistance-focus-of-washington-university-and-national-research-project/article_b192afec-7dbe-59b8-8e06-5e64b7d8795c.html