DiversityNursing Blog

By Darius Tahir

www.modernhealthcare.com 

In the fall of 2012, Nick Valilis was diagnosed with leukemia just as he was starting medical school. In treatment he found it difficult to remember to take his medications at the proper time and in the right order.

“He struggled handling the sheer complexity,” said Rahul Jain, Valilis' classmate at Duke University. “He went from no meds to 10 meds a day. How is an 85-year-old cancer patient supposed to handle that same regimen?” 

Since then, Jain, Valilis and a few other Duke classmates have formed a startup company called TowerView Health with the goal of making it easier for patients to manage their medication regimens. Jain is CEO of the company, which was incorporated last year; Valilis is chief medical officer. They are about to launch a clinical trial, in partnership with Independence Blue Cross and Penn Medicine in Philadelphia, to test whether their technological solution helps patients understand and comply with their drug regimens.

That could be an important innovation. Poor medication adherence is estimated to cause as much as $290 billion a year in higher U.S. medical costs, as well as a big chunk of medication-related hospital admissions.

TowerView has developed software and hardware that reminds patients and their clinicians about medication schedules, and warns them when a patient is falling off track.

Dr. Ron Brooks, senior medical director for clinical services at Independence Blue Cross, said he thinks TowerView's solution is a notable improvement over previous medication-adherence technology. “Most of the apps I've seen are reminder apps,” he said. “It might remind you to take a medication, but you have to input that you actually take it. There's no closing of the loop.” By contrast, TowerView automatically provides reminders and tracking, with the opportunity for clinician follow-up.  

Here's how TowerView's system works. When clinicians prescribe drugs and develop a medications schedule for a patient, the scrips and schedule are sent to a mail-order pharmacy that has partnered with TowerView. The pharmacy splits the medications into the scheduled dosages on a prescription-drug tray. The tray is labeled with the schedule and sent to the patient, who places the tray into an electronic pillbox, which senses when pills are taken out of each tray compartment. 

The pillbox sensors communicate with connected software through a cellular radio when patients have taken their pills and when it's time to remind them—either through a text message, phone call or the pillbox lighting up—that they've missed a dose. The system also compiles information for providers about the patient's history of missed doses, enabling the provider to personally follow up with the patient.

But some question whether tech solutions are the most effective way to improve medication adherence. A 2013 literature review in the Journal of the American Pharmacists Association identified nearly 160 medication-adherence apps and found poor-quality research evidence supporting their use.

Experts say it's not clear whether apps and devices can address the underlying reasons why patients don't comply with their drug regimens. For instance, patients simply might not like taking their drugs because of side effects or other issues. “I'd wager that improved adherence—and a range of other health benefits—are ultimately more likely to be achieved not by clever apps and wireless gadgets, but rather by an empathetic physician who understands, listens and is trusted by her patients,” Dr. David Shaywitz, chief medical officer at DNAnexus, a network for sharing genomic data, recently wrote.

Jain doesn't disagree. He notes that his firm's system empowers empathetic clinicians to provide better care. “This solution allows more of a communication element,” he said. “We'll be able to understand why patients don't take their meds.” 

That system soon will be put to the test in a randomized clinical trial. TowerView and Independence Blue Cross are enrolling 150 diabetic patients who are noncompliant with their medication regimens; half of those participants will receive usual care. The goal is to improve compliance by at least 10% over six months.

If it works, Jain and his company hope to sell the product to insurers and integrated healthcare providers working under risk-based contracts. The idea is that patients' improved adherence will reduce providers' hospitalization and other costs and boost their financial performance.

By Marie Ellis

Imagine swallowing a pill with tiny needles instead of getting an injection. Then again, imagine swallowing a pill with tiny needles. It may sound painful, but according to the researchers who developed the novel capsule - which could replace painful injections - there are no harmful side effects.

The researchers, from the Massachusetts Institute of Technology (MIT) and Massachusetts General Hospital (MGH), have published the results of their study - which tested the microneedle pill in the gastrointestinal (GI) tracts of pigs - in the Journal of Pharmaceutical Sciences.

Though most of us would probably prefer swallowing a pill over having an injection, many drugs cannot be given in pill form because they are broken down in the stomach before being absorbed.

Biopharmaceuticals made from large proteins, such as antibodies - known as "biologics" - are used to treat cancer, arthritis and Crohn's disease, and also include vaccines, recombinant DNA and RNA.

"The large size of these biologic drugs makes them nonabsorbable," explains lead author MIT graduate student Carl Schoellhammer. "And before they even would be absorbed, they're degraded in your GI tract by acids and enzymes that just eat up the molecules and make them inactive."

In an effort to design a capsule that is capable of delivering a wide range of drugs - while preventing degradation and effectively injecting the medicine into the GI tract - Schoellhammer and colleagues constructed the capsule from acrylic, including a reservoir for the drug that is coated with hollow, 5 mm long needles made of stainless steel.

The capsule measures 2 cm long and 1 cm in diameter.

Needle capsule worked safely and effectively in pigs

The team notes that previous studies involving humans who have accidentally swallowed sharp objects have suggested swallowing a capsule coated with short needles could be safe. They explain that there are no pain receptors in the GI tract and that, as a result, patients would not feel any pain.

But to assess whether their capsule could safely and effectively deliver the drugs, the researchers tested the pill in pigs, using insulin in the drug reservoir.

The capsules took more than a week to move through the whole digestive tract, and there were no traces of tissue damage, the researchers say. Additionally, the microneedles effectively injected insulin into the lining of the pigs' stomachs, small intestines and colons, which resulted in their blood glucose levels dropping.

Co-lead author Giovanni Traverso, a research fellow at MIT's Koch Institute for Integrative Cancer Research and gastroenterologist at MGH, notes that the pigs' reduction in blood glucose was faster and larger than the drop observed from insulin injection.

"The kinetics are much better and much faster-onset than those seen with traditional under-the-skin administration," he says. "For molecules that are particularly difficult to absorb, this would be a way of actually administering them at much higher efficiency."

'Oral delivery of drugs is a major challenge'

Though they used insulin for their tests in pigs, the researchers say they envision their capsule being used to deliver biologics to humans.

"This could be a way that the patient can circumvent the need to have an infusion or subcutaneous administration of a drug," says Traverso.

Prof. Samir Mitragotri, a professor at the University of California-Santa Barbara - who was not involved in the research - says:


"This is a very interesting approach. Oral delivery of drugs is a major challenge, especially for protein drugs. There is tremendous motivation on various fronts for finding other ways to deliver drugs without using the standard needle and syringe."

In terms of future modifications, the team plans to alter the capsule so that contractions of the digestive tract slowly squeeze the drug out of the capsule as it travels through the body, and they also want to make the needles out of degradable polymers and sugar that break off, becoming embedded in the gut lining and slowly disintegrating.

Source: http://www.medicalnewstoday.com