Category Archives: Pharmaceuticals

Do You Have A Penicillin Allergy? Fact or Fiction

Are you allergic to penicillin? If so, are you sure about that?

It’s surprisingly common for people to wrongly think they have a penicillin allergy — and that misconception can be dangerous for their health.

Ten percent of all patients in the United States claim to have a penicillin allergy. Of those people, 90 percent are not truly allergic and can tolerate the drug. That means millions of people take alternative antibiotics, which are more expensive and can put their health and potentially the health of others at risk. The solution is a simple allergy test.

A study in the British Medical Journal (BMJ) looked at six years’ worth of medical records for patients in the United Kingdom and found that those with a penicillin allergy had an almost 70 percent greater chance of acquiring a methicillin-resistant Staphylococcus aureus (MRSA) infection and a 26 percent increased risk of Clostridium difficile-related colitis (C. diff.). MRSA and C. diff. are major health risks worldwide. The study compared adults with a known penicillin allergy to similar people without a known penicillin allergy.

People labeled with a penicillin allergy are usually instead given broad-spectrum antibiotics, which may kill off more good bacteria along with the bad. This appeared to increase a patient’s risk of infection with MRSA or C. diff., which are common in our environment and can live without causing any problems on someone’s skin or gut. However, if a broad antibiotic kills off competing good bacteria, MRSA and C. diff. can thrive and start to cause problems.

“Penicillin-related drugs, that whole class … they’re very effective at killing, and they’re very targeted. So for some bacteria they’re still the best. Oldie but goody,” said Kim Blumenthal, lead author of the new study and assistant professor of medicine at Harvard Medical School.

“I have seen so many terrible, terrible outcomes” from C. diff. infections, Blumenthal said, including serious diarrhea, sepsis and death.

“All of us need to understand that antibiotic use is not a free ride, it carries a lot of risk,” said Paul Sax, clinical director of infectious diseases at Brigham and Women’s Hospital. He was not involved in the study but he says the study adds to the “substantial body of evidence” which shows that a penicillin allergy has been linked to longer hospital stays and an increased risk of acquiring resistant infections.

Using non-targeted antibiotics can quickly breed resistant bacteria. “Not only is it harmful to the world and the general population . . . but it’s harmful to the individual patient. So the message to the public is that it could be dangerous to you or me,” said Helen Boucher, director of the Infectious Diseases Fellowship Program at Tufts Medical Center, who was not involved in the study.

“In antibiotic resistance we don’t have a very loud patient advocacy voice . . . and the reasons for that are complicated, but a lot of it has to do with the fact that a lot of the victims aren’t here to speak for themselves because they died,” Boucher said.

The infections are resistant to many known drugs and can quickly become life-threatening. According to the Centers for Disease Control and Prevention, 2 million people, equivalent to the approximate population of Brooklyn, are infected with resistant bacteria every year. At least 23,000 people die each year as a direct result and even more from complications. 

Diagnosing penicillin allergies is challenging. Symptoms such as a rash, nausea or diarrhea could be a sign of allergy, or they might coincidentally occur when someone is taking antibiotics, according to Jonathan Grein, medical director at the Department of Hospital Epidemiology at Cedars Sinai Medical Center in Los Angeles. Children frequently get rashes that are mistaken for penicillin allergies, Blumenthal said.

Even if people are diagnosed correctly as children, they can grow out of an allergy, said Sax.

Which raises the question, what exactly is an allergy? The Internet is full of “answers,” as any late-night Googling hypochondriac can tell you, but an allergy is simply an exaggerated immune response triggered unnecessarily. It can be anything from a rash to trouble breathing.

“Part of the problem is that ‘allergy’ means different things to different people,” said Grein. “Making that distinction between these intolerances and side effects and life-threatening immediate allergic reaction, that’s where the challenge is.”

For example, a patient of Sax’s, in his mid-20s, had a life-threatening heart infection. Penicillin could save him, but his medical record said he was allergic to the drug. Careful questioning by his medical team was able to determine that although he had nausea and diarrhea while on penicillin, he did not have an allergy, Sax said. Knowing this, the hospital administered the appropriate penicillin antibiotic to save his life.

In the case of penicillin, it is important to know that the risks of the allergy diagnosis are sometimes worse than the symptoms of the allergy itself. In most cases, penicillin should only be avoided if the allergy is immediate and life-threatening.

“There are over 30 million Americans who have a penicillin allergy on their record. And there are things we can do,” Blumenthal said.

Examine your own medical record, Blumenthal said. “I would want patients to think, ‘Hmm, am I really allergic to penicillin, or did my mom just tell me and it’s not really true, and should I get that evaluated?’ ”

If it’s been more than 10 years since you were diagnosed, talk to your doctor about getting retested.

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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.  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’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.