Got an antibiotic prescription from your dentist? Chances are, it might be unnecessary

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(Reuters Health) - More than three-quarters of antibiotic prescriptions written by dentists before dental procedures are unnecessary and might do more harm than good, a new U.S. study found.

Dentists write one of every ten antibiotic prescriptions in the United States, and despite national declines, antibiotic prescribing by dentists has held steady over the years, researchers wrote.

Dentists need to be included in the public health conversation regarding appropriate antibiotic use and antimicrobial resistance, lead author Katie Suda of the University of Illinois, Chicago, told Reuters Health by phone.

Antibiotics before dental procedures are recommended for a small subset of patients with certain medical conditions, to prevent a serious heart infection that might arise from the release of oral bacteria into the bloodstream during the procedures. The infection, endocarditis, is an inflammation of the lining of the heart’s chambers and valves.

To see if antibiotics are being prescribed for dental patients according to established guidelines, Suda and her team used an insurance database to analyze prescriptions written during 168,000 dental visits from 2011 to 2015.

They found that 80.9% of prescriptions for antibiotics to be taken before procedures were unnecessary.

Among the 91,438 patients in the study, only 20.9% had a cardiac condition that put them at the highest risk of developing endocarditis and warranted an antibiotic prescription.

Patients with artificial joint implants had more than double the odds of receiving unnecessary antibiotic prescriptions compared with patients who did not have the implants. This is despite the fact that the American Academy of Orthopaedic Surgeons and the American Dental Association now say people with prosthetic joint devices do not need antibiotics before dental procedures.

In particular, the antibiotic clindamycin was highly likely to be unnecessarily prescribed. Clindamycin has been linked with a severe form of diarrhea known as Clostridium difficile (C. diff). A single dose of clindamycin carries the same risk of C. diff infection as a prolonged course of the antibiotic, the researchers wrote, making it all the more alarming that clindamycin was among the overused antibiotics.

Misuse and overuse of antibiotics encourages bacteria to evolve and find ways to resist the medicines. The World Health Organization has called antibiotic resistance a global health emergency.

Why is there so much over-prescribing by dentists? Experts say dentists may face pressure from patients or patients’ cardiologists and orthopedic surgeons, who insist on antibiotics.

“Dentists feel like they are in a really tough position,” said Dr. Emily Spivak of the University of Utah School of Medicine, who wrote an editorial that was published with the study.

“They’re not physicians and they feel like they have to give (antibiotics) because they will be held accountable from the surgeon or the cardiologist if the patient gets an infection,” she told Reuters Health.

Other factors driving unnecessary prescribing may include dentists’ lack of awareness of the most recent guidelines, lack of agreement with these guidelines and the practice of ‘defensive medicine,’ experts said.

Spivak, however, believes the current study may over-inflate the numbers as it includes only commercially insured patients.

The ‘worried well’ or those who suffer from health anxiety may be driving some of this prescribing, she added.

Experts say patients should feel empowered to ask questions when their dentists prescribe antibiotics, and they shouldn’t pressure dentists to provide them with the drugs.

“An informed patient who asks questions can allow for a discussion between the dentist and the patient to truly understand whether they need an antibiotic,” Dr. Salim Virani of the Baylor College of Medicine, told Reuters Health by email.

SOURCE: bit.ly/2KdK109 and bit.ly/2R91tEt JAMA Network Open, online May 31, 2019

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Mesh implants work for bladder leakage, long-term safety unclear

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(Reuters Health) - Several different types of mesh implant surgery may be effective for treating bladder leaks, but the long-term safety and effectiveness of the procedures isn’t yet clear, a new analysis suggests.

Researchers examined data from 175 clinical trials that randomly assigned a total of 21,598 women with stress urinary incontinence to receive different types of surgical treatments.

Over the short-term, three types of surgeries appeared most effective at curing the incontinence. Two newer procedures using slings to support the bladder had cure rates of about 89% and an older abdominal surgery to suture the bladder had a cure rate of about 77%.

“With regard to surgical treatments, there is limited evidence to suggest that there is one ‘best’ option for the treatment of stress urinary incontinence. Rather there are several trade-offs and risks that women need to be aware of and consider alongside their clinician when making their treatment choice,” said study co-author Dawn Craig of Newcastle University in the UK.

“Based on our findings, the jury is still out on the long-term risks of vaginal mesh for stress urinary incontinence,” Craig said by email.

Up to half of adult women experience stress urinary incontinence, when the pelvic floor muscles are too weak to support the bladder. As a result, urine leaks during coughing, sneezing or exercise. Childbirth is a common reason for weak pelvic muscles, and obesity worsens the problem.

Surgical treatment for stress urinary incontinence has evolved over the past two decades from open abdominal operations to support the bladder with sutures to less invasive procedures that insert mesh slings instead. Recently, however, the safety of mesh implants for stress incontinence has come under scrutiny due to reports of severe complications, litigation and product withdrawals, researchers note in The BMJ.

One of the more effective mesh sling options in the study was a traditional suburethral sling, which involves placing a sling under the urethra and using one of a variety of techniques to secure it in place.

The other mesh sling option with similar effectiveness was the midurethral sling, a newer minimally-invasive procedure that enables surgeons to insert a narrow strip of synthetic mesh without the need to secure it in place.

In contrast, the older type of surgery known as an open coloposuspension requires cutting through the abdomen to reach the bladder and then using sutures to support the neck of the bladder, the group of muscles that connect the bladder to the urethra. These muscles tighten to hold urine in the bladder and relax to release urine.

Most of the available safety data was for the newer mesh sling procedures.

Mesh procedures done with one vaginal incision and two groin or thigh incisions - known as transobturator midurethral sling surgery - had more repeat surgeries and groin pain but fewer vascular complications, bladder or urethral perforations, or voiding difficulties than so-called retropubic midurethral surgery done with one vaginal incision and two abdominal incisions.

“We do not have good long-term follow up data for any of these surgeries as the trials analyzed lasted up to five years at most and mesh can cause problems many years after insertion,” said Rufus Cartwright of Oxford University Hospitals NHS Trust in the UK, who co-authored an accompanying editorial.

Some women might be able to address stress urinary incontinence without surgery, previous research has found. Lifestyle changes like avoiding caffeine, drinking small amounts of fluid, using the bathroom at scheduled times throughout the day and doing exercises that target the pelvic floor muscles can improve bladder control.

“Women should consider surgery for incontinence if their symptoms are severely affecting their quality of life, and they haven’t responded to conservative treatment (pelvic floor exercises),” Cartwright said by email. “The choice between the different procedures should be based on a process of shared decision making with the surgeon.”

SOURCE: bit.ly/31w78Jv and bit.ly/2KeSIIt The BMJ, online June 5, 2019.

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Many epinephrine self-injectors still potent long after expiration date

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(Reuters Health) - EpiPens and other autoinjectors filled with epinephrine to treat severe allergic reactions may still be potent enough to work many months past their labeled expiration date, according to a new study that concludes patients might need expensive refills less often.

These autoinjectors contain a pre-set dose of epinephrine, a life-saving drug used by people at risk of experiencing anaphylaxis, a severe allergy attack. Untreated, anaphylactic shock can be fatal because blood pressure can drop suddenly and airways can narrow, making it difficult to breathe.

Patients who need these life-saving devices must carry at least one with them at all times and have access to one everywhere they go. Soaring prices and out-of-pocket costs for the autoinjectors have made it increasingly difficult for many patients to keep throwing out and replacing unused devices when they expire, researchers note in the Journal of Allergy and Clinical Immunology: In Practice.

The U.S. Food and Drug Administration (FDA) requires autoinjector expiration dates to ensure that the devices never contain less than 90% of the original dose of epinephrine, the study team notes.

For the study, researchers tested the contents of 46 different autoinjectors to see how much epinephrine remained after the expiration dates on the labels. Half of the devices were tested at least two years after their labeled expiration date. At this point, 80% of the devices still retained 90% or more epinephrine, indicating they were still effective under the FDA rules.

“If the expiration dating on these devices was changed, this means that patients would not need to replace their auto-injectors as frequently, limiting cost to them, their insurance, and the healthcare system, while still feeling secure that they have access to adequate treatment for anaphylactic reactions,” said lead study author Lynn Kassel of Drake University College of Pharmacy & Health Sciences in Des Moines, Iowa.

Devices six months past their labeled expiration date in the study still had 100% of the original epinephrine dose. One year after the labeled expiration date, devices still had 95% of the original epinephrine dose.

And all of the autoinjectors tested that were up to 30 months beyond their labeled expiration date still had 90% of the dose remaining.

The study tested far too few devices to help determine with certainty whether all epinephrine autoinjectors in the U.S. might be safely used past their expiration dates, Kassel said by email.

The authors also note that they did not test the expired injectors’ effectiveness in stopping an anaphylaxis episode.

“Until the FDA changes the expiration dating guidance for these devices, patients with anaphylactic allergies should carry auto-injectors that have not yet expired,” Kassel advised.

“The greatest risk of using an expired auto-injector is that the epinephrine is no longer potent enough to combat the anaphylactic reaction, and this could result in death or critical illness.”

Right now, the expiration date is 18 months from the time the product is manufactured, a duration that is shorter than the expiration date for most other medications, said Dr. Kao-Ping Chua of the C.S. Mott Children’s Hospital and the University of Michigan Medical School in Ann Arbor.

While the study results build on a growing body of evidence suggesting that expiration dates for epinephrine autoinjectors could be extended, in the meantime, patients should use the devices as labeled, Chua, who wasn’t involved in the study, said by email.

“I don’t think anyone should postpone refilling an epinephrine auto-injector if they can afford it,” Chua said. “In a life-or-death situation, you want to have as much certainty as possible that the rescue medication is going to work.”

SOURCE: bit.ly/2F7WrTT Journal of Allergy and Clinical Immunology: In Practice, online May 28, 2019.

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IBM, Walmart, Merck in blockchain collaboration with FDA

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FILE PHOTO: The Walmart logo in New York, U.S., May 1, 2018. REUTERS/Brendan McDermid/File Photo

(Reuters) - IBM, Merck and Walmart have been chosen for a U.S. Food and Drug Administration pilot program that will explore using blockchain technology to improve the security of prescription drug supply and distribution.

The companies said they would work with consultancy KPMG to create a shared blockchain network that will allow real-time monitoring of products in the pharmaceutical supply chain.

The project has been authorized under the U.S. Drug Supply Chain Security Act (DSCSA) that was set up to increase regulatory oversight of counterfeit, stolen, contaminated or otherwise harmful drugs.

The FDA has previously used the DSCSA to issue a warning letter to drug distributor McKesson Corp for violations involving opioid medications.

Opioids have been tied to thousands of overdose deaths and state and local governments across the United States have filed lawsuits seeking to hold pharmaceutical companies responsible for the epidemic of abuse.

The new project is aimed at reducing the time needed to track and trace prescription drugs, improving access to reliable distribution information and ensuring products are handled appropriately and stored at the right temperature while being distributed, the companies said in a statement.

Blockchain technology, originally conceived a decade ago as the basis for the cryptocurrency bitcoin, will help stakeholders establish a permanent record and can be integrated with existing systems used to trace products while they are distributed.

The project is scheduled to be completed in the fourth quarter of 2019 and results will be published in a report, the companies said.

Reporting by Tamara Mathias in Bengaluru; Editing by Shinjini Ganguli

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