Tag Archives: Antibiotic Prescribing

Patient Safety Is Jeopardized by Unnecessary Antibiotics

Like any medication, antibiotics carry certain risks. While they are critical to treating a wide range of conditions, from strep throat and urinary tract infections to bacterial pneumonia and sepsis, these drugs also increase a patient’s chances of developing Clostridium difficile infections—which can result in life-threatening diarrhea—and can lead to adverse drug events, including allergic reactions.

Because of these dangers, it is important to use antibiotics only when needed. However, many antibiotics prescribed in the United States are unnecessary.

See what the research tells us and what leading antibiotic use experts say about inappropriate prescribing, the threat it poses to patient health, and how improved antibiotic stewardship can help to protect patient safety.

Improving Outpatient Antibiotic Use: The Role of Pediatricians

“For a long time, we believed that ‘erring on the safe side’ for our patients might be to prescribe an antibiotic just in case, even when we weren’t completely certain of the diagnosis. … Increasingly, we’re realizing that ‘being on the safe side’ often means not prescribing an antibiotic.”

Adam Hersh, M.D., University of Utah, Primary Children’s Hospital

 

Improving Outpatient Antibiotic Use: The Role of Emergency Room Doctors

“Acute bronchitis is one of the very common conditions we see in the emergency department and it’s also one … for which we have the best evidence that antibiotics should not be used, as these infections are typically caused by viruses and will resolve on their own. … I’ve seen … patients that received antibiotics for simple bronchitis or sinusitis that probably didn’t need the antibiotic, and then came in with life-threatening diarrheal illness, known as C. difficile infection.”

Larissa May, M.D., University of California, Davis

 

Improving Outpatient Antibiotic Use: The Role of Pharmacists

“I’ve had patients with antibiotic-associated adverse drug reactions … serious ones, such as Stevens-Johnson’s syndrome and [the] development of C. difficile.”

Katie Suda, Pharm.D., M.S., University of Illinois, Chicago

 

Improving Outpatient Antibiotic Use: The Role of Primary Care Physicians

“There’s a misperception on the part of doctors that patients want antibiotics. … [There] are millions of individual visits where we’re doing the wrong thing by our patients. We’re giving them medicines that they don’t need.”

Jeff Linder, M.D., M.P.H., Brigham and Women’s Hospital, Harvard Medical School

 

One study estimated that a 30 percent reduction in broad-spectrum antibiotic use in hospitals could result in a 26 percent reduction in hospital-associated C. difficile infections.

Improving Outpatient Antibiotic Use: The Role of Nurse Practitioners

“What is concerning is a lot of people think every sore throat is strep throat, and they want antibiotics. The reality is that most sore throats are not strep throat. It is important that we make sure that we don’t give antibiotics just for a viral sore throat. … If we continue to prescribe antibiotics inappropriately … we will get to a point where children are not responding to antibiotics. And that’s very scary.”

Teri Woo, Ph.D., National Association of Pediatric Nurse Practitioners

 

David Hyun, M.D., works on The Pew Charitable Trusts’ antibiotic resistance project.

 

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

https://www.pewtrusts.org/en/research-and-analysis/articles/2017/03/16/unnecessary-antibiotic-use-jeopardizes-patient-safety

U.S. Food and Drug Administration Advises Serious Side Effects Associated With Fluoroquinolone Antibacterial Medication

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The Division of Drug Information (DDI)- serving the public by providing information on human drug products and drug product regulation by FDA.


The U.S. Food and Drug Administration is advising that the serious side effects associated with fluoroquinolone antibacterial drugs generally outweigh the benefits for patients with sinusitis, bronchitis, and uncomplicated urinary tract infections who have other treatment options.  For patients with these conditions, fluoroquinolone should be reserved for those who do not have alternative treatment options. 

The new FDA ruling calling for restricted use of fluoroquinolones affects five prescription antibiotics: ciprofloxacin (Cipro), levofloxacin (Levaquin), moxifloxacin (Avelox), ofloxacin (Floxin), and gemifloxacin (Factive). All are also available as generics.

https://cdifffoundation.org/2016/05/05/a-study-provides-data-that-between-2010-and-2011-throughout-u-s-at-least-30-percent-of-antibiotics-unnecessarily-prescribed/

 

ANTIBIOTIC STEWARDSHIP PROGRAM UPDATES:

https://cdifffoundation.org/2016/04/29/antibiotic-stewardship-program-and-updates-from-sources-cdc-pew-charitable-trusts-with-idsa-and-shea-guidelines/

 

For Additional Information Regarding This Topic – Please Visit The Following Consumer Article:

http://www.consumerreports.org/drugs/fluoroquinolones-are-too-risky-for-common-infections/

An FDA safety review has shown that fluoroquinolones when used systemically (i.e. tablets, capsules, and injectable) are associated with disabling and potentially permanent serious side effects that can occur together.  These side effects can involve the tendons, muscles, joints, nerves, and central nervous system. 

As a result, we are requiring the drug labels and Medication Guides for all fluoroquinolone antibacterial drugs to be updated to reflect this new safety information.  We are continuing to investigate safety issues with fluoroquinolones and will update the public with additional information if it becomes available.

Patients should contact your health care professional immediately if you experience any serious side effects while taking your fluoroquinolone medicine.   Some signs and symptoms of serious side effects include tendon, joint and muscle pain, a “pins and needles” tingling or pricking sensation, confusion, and hallucinations.  Patients should talk with your health care professional if you have any questions or concerns.

Health care professionals should stop systemic fluoroquinolone treatment immediately if a patient reports serious side effects, and switch to a non-fluoroquinolone antibacterial drug to complete the patient’s treatment course.  

Fluoroquinolone drugs work by killing or stopping the growth of bacteria that can cause illness.

We previously communicated safety information associated with systemic fluoroquinolone antibacterial drugs in August 2013 and July 2008.  The safety issues described in this Drug Safety Communication were also discussed at an FDA Advisory Committee meeting in November 2015. 

We urge patients and health care professionals to report side effects involving fluoroquinolone antibacterial drugs and other drugs to the FDA MedWatch program, using the information in the “Contact FDA” box at the bottom of the page.

For more information, please visit: Fluoroquinolone.

 

IDSA and SHEA Release New Antibiotic Stewardship Guidelines

In The News

April 2016

Preauthorization of broad-spectrum antibiotics and prospective review after two or three days of treatment should form the cornerstone of antibiotic stewardship programs to ensure the right drug is prescribed at the right time for the right diagnosis. These are among the numerous recommendations included in new guidelines released by the Infectious Diseases Society of America (IDSA) and Society for Healthcare Epidemiology of America (SHEA) and published in the journal Clinical Infectious Diseases.

“Initially, antibiotic stewardship was more focused on cost savings, and physicians responded negatively to that, because they often felt it was best to give patients the newest, most expensive drug,” said Tamar Barlam, MD, lead co-author of the guidelines, director of the antibiotic stewardship program at Boston Medical Center and associate professor of medicine at Boston University Medical School. “While these programs do save hospitals money, their most important benefit is that they improve patient outcomes and reduce the emergence of antibiotic resistance. When we say stewardship, we really mean stewardship, and increasingly, doctors are realizing it’s important and necessary.”

The White House has called for hospitals and healthcare systems to implement antibiotic stewardship programs by 2020 to ensure appropriate use of these vital drugs and reduce resistance, an escalating problem that threatens the ability to effectively treat often life-threatening infections.

The new guidelines replace those originally created to help with the development of programs when antibiotic stewardship was in its infancy, and instead focus on specific strategies that the evidence suggests are most beneficial to ensure the program will be effective and sustainable. They also note it is key that these programs tailor interventions based on local issues, resources and expertise. To ensure that, the guidelines recommend the programs be led by physicians and pharmacists and rely on the expertise of infectious diseases specialists.

“We want hospital administrators to understand the importance of giving antibiotic stewardship their full support to ensure its success,” said Sara Cosgrove, MD, MS, lead co-author of the guidelines, president-elect of SHEA and associate professor of medicine and epidemiology at Johns Hopkins University, and director of the antimicrobial stewardship program and associate hospital epidemiologist at The Johns Hopkins Hospital, Baltimore. “Distributing a few brochures or holding grand rounds won’t do it. It’s vital that antibiotic stewardship be integrated into the hospital’s culture and that infectious disease specialists guide strategies that have been shown to work.”

The guidelines note that more research needs to be done to determine how to ensure antibiotic stewardship is most effective. However, the best evidence to date suggests a number of components, including the following, will help ensure the implementation of an effective antibiotic stewardship program.

  • Preauthorization or prospective audit and feedback – Targeted antibiotics, such as those that treat emerging drug-resistant bacterial infections, should require preauthorization. This means providers need to get approval to use antibiotics before they are prescribed. Prospective audit and feedback can be an alternate strategy or combined with preauthorization. Prospective audit allows antibiotic stewards to engage the prescribing clinician after the antibiotic has been used, typically after two or three days, to optimize antibiotic treatments. Both methods can reduce antibiotic misuse and decrease the development of resistance. Hospitals should choose one or both of these methods as part of their program based on their local resources and expertise.
  • Syndrome-specific interventions – The guidelines recommend focused multifaceted interventions for the treatment of specific syndromes, rather than trying to improve treatment of all infections at once. For example, Dr. Barlam said those leading a hospital’s antibiotic stewardship program might take a close look at management of pneumonia during winter, including making recommendations to shorten the amount of time people are treated and switching to an oral agent more quickly, and then measuring the results of those interventions. In the fall, the program might focus on urinary tract infections and then several months later, switch to skin and soft tissue infections. “This method makes stewardship more manageable and provides a targeted and clear treatment message rather than trying to disseminate 100 different lessons at the same time,” she said.
  • Rapid diagnostic testing – The guidelines note that rapid diagnostic testing of respiratory specimens can help determine if the cause is viral and therefore reduce the inappropriate use of antibiotics. They also note that the rapid testing of blood cultures in addition to conventional culture is helpful, but should be guided by the antibiotic stewardship team for maximum benefit to the patient.

Other recommendations include reducing the use of antibiotics associated with Clostridium difficile infection, implementing antibiotic time-outs and other strategies to encourage prescribers to perform routine reviews of regimens and using computerized clinical decision support if possible.

The guidelines do not recommend relying solely on passive educational materials to implement antibiotic stewardship because any improvement likely will not be sustained. Lectures and brochures should be used to supplement strategies such as antibiotic preauthorization and prospective audit and feedback, the authors note.

AT A GLANCE

  • Preauthorization and prospective review of antibiotics are among the many recommendations to ensure antibiotic stewardship programs are most effective, suggest new guidelines from IDSA/SHEA.
  • Antibiotic stewardship programs should be led by physicians and pharmacists, including ID specialists, who have the expertise and education to ensure the right drug is being prescribed at the right time for the right diagnosis.
  • Antibiotic stewardship programs must be based on the specific problems identified by the healthcare facility and a realistic examination of available resources to ensure interventions are performed with consistency.
  • These programs have been shown to improve patient outcomes, reduce antibiotic resistance and save money.

In addition to Drs. Barlam and Cosgrove, the antibiotic stewardship program guidelines panel includes: Lilian Abbo, Conan MacDougall, Audrey N. Schuetz, Ed Septimus, Arjun Srinivasan, Timothy Dellit, Yngve T. Falck-Ytter, Neil Fishman, Cindy W. Hamilton, Timothy C. Jenkins, Pamela A. Lipsett, Preeti N. Malani, Larissa S. May, Gregory J. Moran, Melinda M. Neuhauser, Jason Newland, Christopher A. Ohl, Matthew Samore, Susan Seo and Kavita K. Trivedi.

IDSA and SHEA individually have published myriad treatment guidelines and together have published several, including the prevention of healthcare-associated infections and antimicrobial prophylaxis in surgery.

As with other IDSA and SHEA guidelines, the antibiotic stewardship guidelines will be available in a smartphone format and a pocket-sized quick-reference edition.

The full guidelines are available free on the

IDSA website at http://www.idsociety.org

 

SHEA website at http://www.shea-online.org.

 

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

http://www.eurekalert.org/pub_releases/2016-04/idso-nas041216.php

 

C diff Spores and More Global Broadcasting Network and Guests Dr. Srinivasan and Dr. Hicks of the CDC Discuss Antibiotic Resistance

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C. diff. Spores and More , Global Broadcasting Network – innovative and educational interactive healthcare talk radio show discuss antibiotic resistance and what everyone can do to join in the fight against it with guests Dr. Arjun Srinivasan and
Dr. Lauri Hicks on Tuesday, February 9th at 10 AM Pacific Time on VoiceAmerica Health and Wellness Channel

Bringing guests together, such as Dr. Arjun Srinivasan, MD and Dr. Lauri Hicks, DO from the Center of Disease Control and Prevention (CDC), one of the leading government healthcare organizations in the U.S., and internationally recognized experts on antibiotic resistance has built a loyal listenership and continue to inform and educate listeners’ worldwide.

C.diff. Spores and More” is broadcast live every Tuesday at 10 AM Pacific Time on the VoiceAmerica Health and Wellness channel, officially sponsored by Clorox Healthcare. Archived C. diff. Spores and More shows can be found Here.

“I am so proud to be the Senior Executive Producer of the “C. diff. Spores and More,” program as it continues to raise awareness, on a global level, of the overuse of antibiotics. Having guests; Dr. Arjun Srinivasan, MD and Dr. Lauri Hicks, DO truly affect change in both the leadership and education guiding the public and raising awareness in many areas of health care,” stated Robert Ciolino, Senior Executive Producer VoiceAmerica.

About The C diff Foundation Executive Director
Nancy C Caralla, hosts “C. diff. Spores and More” Global Broadcasting Network with a team focus on educating, and advocating for C. diff. infection prevention, treatments, and environmental safety – and more — worldwide.

For information please visit www.cdifffoundation.org

Listen in on Tuesday, February 9th at 10:00 Pacific Time–

https://cdifffoundation.org/c-diff-radio/

Emphasize The Importance Of Antibiotic Stewardship To Control C. difficile Worldwide

Antibiotic Resistance – It’s Everybody’s Business

Antibiotic Resistance Know The Facts

As the incidence of Clostridium difficile (C. diff) infection spirals, physicians should emphasize the importance of antibiotic stewardship.

A study published in the journal affiliated with the National Foundation for Infectious Diseases (NFID) summarized a recent NFID webinar by Carolyn V. Gould, MD, and L. Clifford McDonald, MD, Centers for Disease Control and Prevention (CDC) and Thomas M. File, Jr., MD, Editor-in-Chief, Infectious Diseases in Clinical Practice.

While C. diff is mainly a significant hospital-acquired infection, recently approximately 5% of C. diff cases are diagnosed outside hospitals.

Since prior antibiotic treatment is the primary risk factor for C. diff, antibiotic stewardship is considered a key factor in controlling significant spikes in incidences.

Antibiotics are capable of disrupting intestinal balance, thereby creating the opportunity for C. diff spores to produce diarrhea-causing toxins.

According to the CDC, there are six essential methods to consider for C. diff prevention:

·      Careful prescribing and use of antibiotics
·      Early and reliable diagnosis
·      Immediate isolation of infected patients
·      Contact precautions – wearing gloves and gowns for all contact with the patient and patient-care environment
·      Adequately cleaning patient care environments; using an EPA-registered C. diff sporicidal disinfectant
·      Effective communication about C. diff status when patients are transferred between healthcare facilities

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

http://www.hcplive.com/medical-news/immediate-action-necessary-to-control-c-diff-infection

Obama Administration Issues Detailed Plan National Action Plan for Combating Antibiotic-Resistant Bacteria

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National Action Plan for Combating Antibiotic-Resistant Bacteria.

The Obama administration has issued a detailed plan to address the problem of antibiotic resistance, complete with milestones to help ensure the goals are actively addressed.

Drug-resistant bacteria cause 23,000 deaths and two million illnesses a year in the United States, according to the Centers for Disease Control and Prevention. Resistance also threatens animal health and agriculture, said the White House.

The 63-page National Action Plan for Combating Antibiotic-Resistant Bacteria, released                     March 27, 2015 was developed by a task force made up of representatives from at least a dozen federal agencies. The task force began meeting in September 2014, taking its cues from an executive order issued by President Obama on September 18, 2014, and from recommendations in a report on antibiotic resistance that was issued by the President’s Council of Advisers on Science and Technology around the same time.

The action plan aims “to enhance domestic and international capacity to prevent and contain outbreaks of antibiotic-resistant infections; maintain the efficacy of current and new antibiotics; and develop and deploy next-generation, diagnostics, antibiotics, vaccines, and other therapeutics,” according to the White House.

Five Goals

The plan sets 1-, 3-, and 5-year targets in each of the five overarching goals, which are to:

  • slow the emergence of resistant bacteria and prevent the spread of resistant infections;
  • strengthen national one-health surveillance efforts to combat resistance (the “one-health” approach to disease surveillance integrates data from multiple monitoring networks, according to the White House);
  • advance development and use of rapid and innovative diagnostic tests for the identification and characterization of resistant bacteria;
  • accelerate basic and applied research and development for new antibiotics, other therapeutics, and vaccines; and
  • improve international collaboration and capacities for antibiotic resistance prevention, surveillance, control, and antibiotic research and development.

Having specific benchmarks is something that the Infectious Diseases Society of America (IDSA) has advocated, said Amanda Jezek, vice president of public policy and government relations at IDSA. “That helps ensure that this isn’t just an action plan that will sit on the shelf and collect dust,” Jezek told Medscape Medical News.

Hospitals will be required to implement programs to increase infection controls, such as judiciously washing hands, hospital surfaces and equipment, and reducing the use of antibiotics in patients.

Doctors working with the government’s Medicare and Medicaid health plans will be required to report their prescribing patterns for antibiotics, particularly when used to treat non-bacterial infections, such as common colds.

The plan calls for CDC to increase its screening of people arriving from countries with high rates of multi-drug resistant tuberculosis. The CDC currently screens 500,000 such arrivals per year, and the plan calls for doubling that within five years.

 

Urgent and Serious

Among other targets, the plan sets goals for eradicating pathogens that have been labeled urgent or serious threats by the Centers for Disease Control and Prevention. The 2020 targets include:

  • a 50% reduction from 2011 estimates in the incidence of Clostridium difficile,
  • a 60% reduction in hospital-acquired Carbapenem-resistant Enterobacteriaceae infections,
  • a 35% reduction in hospital-acquired multidrug-resistant Pseudomonas species infections, and
  • a 50% reduction from 2011 estimates in methicillin-resistant Staphylococcus aureus bloodstream infections.

Also by 2020, the action plan seeks a 50% reduction in inappropriate antibiotic use in outpatient settings and a 20% reduction in inpatient settings, as well as routine reporting of antibiotic use and resistance data to Centers for Disease Control and Prevention’s National Healthcare Safety Network by 95% of Medicare-eligible hospitals.

The plan also envisions by 2020 the development and wide dissemination of rapid diagnostic tests that can be used in a physician’s office or at the hospital bedside to distinguish between viral and bacterial infections, and thus help ensure more appropriate use of therapeutics.

Under research and development, the plan calls for the characterization of the gut microbiome of at least one animal species raised for food to potentially treat bacterial diseases without antibiotics, and at least three new probiotic therapies for animals by 2020.

In the same time frame, the plan dictates the development of at least two new drug candidates or nontraditional therapeutics and/or vaccines for the prevention of human disease.

The action plan also outlines proposals to work with other governments around the world to enhance the capacity to identify resistant pathogens and to help low- and middle-income countries develop stewardship plans.

$1 Billion to Start?

The White House said the plan’s aspirations are “consistent” with the president’s fiscal 2016 budget proposal, which seeks more than $1 billion to combat antibiotic resistance.

Jezek, from the IDSA, said the $1 billion is a good start and notes that there is bipartisan support for battling antibiotic resistance. “To me, the big question is, Can we get Congress to actually allocate all of that money?” she said.

The automatic budget cuts known as sequestration loom large over any request for funds that are not for mandatory programs, which could make it hard to get the full 2016 request from lawmakers, said Jezek.

The IDSA is also calling on the federal government to ensure the establishment of antibiotic stewardship programs in all healthcare facilities and to pass incentives to encourage drug, diagnostic, and vaccine development.

The federal interagency task force is scheduled to provide a progress report on the action plan within 6 months of its release — by September. It will then make annual progress reports and make recommendations to modify goals if necessary.

The task force is also supposed to work in conjunction with the Presidential Advisory Council on Combating Antibiotic Resistance, a 30-member board that has yet to be constituted.

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

http://news.yahoo.com/white-house-crafts-first-ever-plan-fight-superbugs-215855870–finance.html;_ylt=AwrBT9znhBVVhrYAkr1XNyoA;_ylu=X3oDMTEza2JuOW9lBGNvbG8DYmYxBHBvcwMxBHZ0aWQDVklQNTk2XzEEc2VjA3Nj

Antibiotic Prescribing; Clinicians Know the Recommendations

Clinicians know the recommendations regarding when and when not to prescribe antibiotics, but they do not always follow them, according to in-depth interviews with 36 Physicians, Nurse Practitioners (NPs), and Physician Assistants (PAs).

Guillermo Sanchez, MPH, from the Centers for Disease Control and Prevention, Atlanta, Georgia, and colleagues report the results of their interview-based study in an article published online November 13, 2014  in Emerging Infectious Diseases.

Reasons for straying from the guidelines range from believing that a non-recommended antibiotic will work better for a patient, particularly when considering allergies or complicated medical histories; concern about patient dissatisfaction; fear of related infection; and concerns about legal action.Clinicians indicated that although they are concerned patients could build up a resistance to antibiotics, those concerns do not usually affect their choice of drug.

Researchers Recorded Telephone Interviews

The researchers conducted in-depth interviews via digitally recorded telephone calls and transcribed the recordings to accurately assess primary care providers’ prescribing behaviors. The breakdown of participants was nine pediatricians, nine family medicine physicians, nine internal medicine physicians, five NPs, and five PAs.

Dr. Sanchez and colleagues used a screening questionnaire to recruit potential participants from a nationwide marketing database. Eligible participants spent at least half of their time with patients in a primary care setting and were older than 30 years. The authors excluded clinicians with a board certification outside of primary care or if they had practiced medicine for more than 30 years.

Before the interview, participants filled out a questionnaire that asked them to rank 12 factors on their influence on antibiotic selection, such as illness severity, patient demand, or practice guidelines. They then discussed their answers with trained interviewees during the recorded interviews.

To evaluate clinical decision-making, each participant received a specialty-appropriate clinical vignette about a patient who had a diagnosis of an acute bacterial infection. The participant was asked to explain why he or she chose an antibiotic and why other primary care providers might choose non-recommended antibiotics.

The researchers found that participants had inconsistent definitions of broad- and narrow-spectrum antibiotics. “Although some participants correctly identified amoxicillin as a narrow-spectrum agent, and azithromycin as a broad-spectrum agent, many participants were uncertain of the spectrum of antimicrobial activity for these 2 widely used antibiotics.”

In addition, clinicians often thought broad-spectrum antibiotics would be more successful in curing an infection, although those beliefs are unfounded, the authors say. That thinking may regularly lead to inappropriate selection and should be addressed, the authors note.

Clinicians, however, were more likely to choose narrow-spectrum drugs when the diagnosis was more certain or when they saw a patient’s condition as relatively benign.

The authors have disclosed no relevant financial relationships.

Source: Medscape

To read the article in its entirety :

http://www.medscape.com/viewarticle/834923?nlid=70147_2981&src=wnl_edit_dail&uac=206986BK