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PEER-REVIEWED MEDICAL JOURNAL PUBLISHES LANDMARK STUDY ON EFFICACY AND SAFETY OF FDgard® (COLM-SST), DEMONSTRATING RAPID REDUCTION OF FUNCTIONAL DYSPEPSIA (FD OR RECURRING, MEAL-TRIGGERED INDIGESTION) SYMPTOMS WITHIN 24 HOURS

  • FDgard® (COLM-SST), a solid-state microsphere formulation of caraway oil and l-Menthol, taken daily and proactively 30-60 minutes before meals, showed statistically significant, rapid reduction of Functional Dyspepsia (FD) symptoms within 24 hours and, additionally, relief of severe FD symptoms.
  • FDREST clinical trial with FDgard represents an important medical advance, as no previous trials have shown rapid relief of FD symptoms. There are no approved products for this highly prevalent condition.
  • In FDREST, patients received greater and more durable benefits with the addition of FDgard taken daily and proactively to their typical medical regimen.
  • FDREST is the first clinical trial in FD to use patented, Site Specific Targeting (SST®) technology to deliver the FDgard formulation to the upper belly (duodenum), the primary site of disturbance in FD.
  • FDgard represents an effective, safe and well-tolerated option to address the unmet medical needs of millions of adults with FD.

Reporter: Gail S. Thornton

Boca Raton Fl., – (April 30, 2019) – IM HealthScience today announced that Clinical and Translational Gastroenterology (CTG), a peer-reviewed medical journal, has published the U.S. results of a landmark, double-blind, placebo-controlled study, FDREST™ (Functional Dyspepsia Reduction Evaluation and Safety Trial), which showed statistically significant, rapid reduction of Functional Dyspepsia (FD or recurring, meal-triggered indigestion) symptoms within 24 hours and, additionally, relief of severe FD symptoms.

The study, entitled “A Novel, Duodenal-Release Formulation of a Combination of Caraway Oil and L-Menthol for the Treatment of Functional Dyspepsia: A Randomized Controlled Trial,” is now available to the public via open access on the Clinical and Translational Gastroenterology website. Clinical and Translational Gastroenterology, published on behalf of the American College of Gastroenterology (ACG), is dedicated to innovative clinical work in the field of gastroenterology and hepatology.

The FDREST study demonstrated that patients who took COLM-SST (FDgard®) on a daily and proactive basis, 30 to 60 minutes before meals, along with commonly used off-label FD medications versus patients who took placebo along with commonly used off-label FD medications, experienced a statistically significant, rapid reduction of FD symptoms within 24 hours across the FD study population.

This study had a higher hurdle than previous studies on a similar combination of ingredients. Firstly, concomitant medications for FD symptoms were allowed in order to assess FDgard in a real-world setting. Second, only a subgroup of patients in FDREST was categorized into the high-symptom burden, while they constituted the entire groups in previous studies. Among this subgroup of patients with the high-symptom burden, FDgard showed efficacy at 24 hours. In spite of the polypharmacy and use of rescue medications for FD, after 48 hours of first dose, FDgard helped further improve symptoms at 4 weeks, especially in those high-symptom burden patients. In all cases, FDgard was safe and well-tolerated.  

The study results of FDREST were first presented at Digestive Disease Week (DDW), the largest gathering of gastroenterologists, in May 2017.

Study Commentary

Commenting on the study, lead author William Chey, M.D., FACG, Director in the Division of Gastroenterology, Michigan Medicine Gastroenterology Clinic, Ann Arbor, said, “This landmark study was designed to answer a very important scientific question about the effectiveness, safety, and tolerability of a novel and innovative formulation of caraway oil and l-Menthol designed as solid state, enteric coated microspheres for targeted duodenal release for FD. In patients taking their usual medications for FD, FDgard was found to be effective, safe and well tolerated in rapidly reducing symptoms and in relieving severe symptoms.” Chey continued, “The positive finding at 24 hours is clinically important as symptoms are often triggered by a meal and patients are looking for rapid relief of those symptoms.”

The study authors also cited the importance of utilizing the microsphere-based site-specific targeting of FDgard (caraway oil and l-Menthol, the active ingredient in peppermint oil) to the duodenum. They wrote, “This site (duodenum) was targeted primarily due to mounting evidence that gastroduodenal mucosal integrity and low-grade inflammation play a role in FD. Furthermore, studies have shown that caraway oil and peppermint oil act on the duodenum to induce smooth muscle relaxation, and that l-Menthol has anti-inflammatory effects.” This may help normalize motility effects.

About FDREST™

FDREST™ (Functional Dyspepsia Reduction and Evaluation Safety Trial) was a multi-centered, post-marketing, parallel group, U.S-based study conducted at seven university-based or gastroenterology research-based centers (study period July 1, 2015, to September 14, 2016). The study was designed to compare the efficacy, safety and tolerability of FDgard plus commonly used, off-label medications for FD vs. a control group of placebo plus commonly used, off-label medications prescribed for FD.

Ninety-five patients were enrolled (mean age = 43.4 years; 75.8 percent women). At 24 hours, the active arm reported a statistically significant reduction in Postprandial Distress Syndrome (PDS) symptoms (P = 0.039), and a nonsignificant trend toward benefit of Epigastric Pain Syndrome (EPS) symptoms (P = 0.074). In patients with more severe symptoms, approximately three-quarters showed substantial global improvement (i.e., clinical global impressions) after 4 weeks of treatment vs. half in the control arm. These differences were statistically significant for patients with EPS symptoms (epigastric pain or discomfort and burning) (P = 0.046), and trending toward significance for patients with PDS symptoms (early satiety, abdominal heaviness, pressure and fullness) (P = 0.091). There were no statistically significant differences between groups for Global Overall Symptom scores for the overall population at 2 and 4 weeks.

Dr. Chey said, “The results of this high-quality study highlight an advance in the management of FD, as current off-label medications such as PPIs, H2RAs and antidepressants offer only a modest level of therapeutic gain over placebo and may be associated with adverse events, especially with continued use. FDgard addresses a significant unmet medical need for a product to help manage symptoms in the 1 in 6 adults suffering from this common disorder.”

About Functional Dyspepsia (FD)

Functional dyspepsia is a very common disorder affecting 11 percent – 29.2 percent of the world’s population1, making it comparable in prevalence to IBS. However, unlike IBS, there is no FDA approved product to treat FD. Sufferers are often treated off-label with prescribed proton pump inhibitors (PPIs), histamine type-2 receptor antagonists (H2RAs), antidepressants, and prokinetics. While offering relief to a portion of FD patients, some of these have been associated with adverse events. Functional dyspepsia can have a negative effect on workplace attendance and productivity, with associated costs estimated in excess of $18 billion annually.2

In FD, which is typically recurring, meal-triggered indigestion with no known organic cause, the normal digestive processes are disrupted along with digestion and absorption of food nutrients. FD is accompanied by symptoms such as epigastric pain or discomfort, epigastric burning, postprandial fullness, inability to finish a normal sized meal, heaviness, pressure, bloating in the upper abdomen, nausea, and belching. When doctors diagnose FD, they often identify patients as those who have these symptoms for at least three months, with symptom onset six months previously.

About FDgard®

FDgard® is a nonprescription medical food designed to address the unmet medical need for products to help manage Functional Dyspepsia (FD or recurring, meal-triggered indigestion) and its accompanying symptoms.  FDgard capsules contain caraway oil and l-Menthol, the primary component in peppermint oil, for the dietary management of FD. These two main ingredients are specially formulated to be available in a solid state.  With patented Site Specific Targeting (SST®) technology pioneered by IM HealthScience, FDgard capsules release individually triple-coated, solid-state microspheres of caraway oil and l-Menthol quickly and reliably where they are needed most in FD — the duodenum or upper belly. The l-Menthol helps with smooth muscle relaxation and provides analgesic and anti-inflammatory activities.3–5 Caraway oil helps mitigate the effect of gastric acid on the stomach wall and also helps to normalize gallbladder function and may help to normalize motility in the small intestine (primarily the duodenum) and in the stomach.6,7 In addition to caraway oil and l-Menthol, FDgard also provides fiber and amino acids (from gelatin protein). These ingredients have additional positive effects on the gut wall and thus help toward normalizing digestion and absorption.            

Caraway oil and peppermint oil have a history of working in FD. In multiple clinical studies, the combination of caraway oil and peppermint oil has been shown to manage FD and its accompanying symptoms, such as reducing the intensity of epigastric pain, pain frequency, dyspeptic discomfort, and the intensity of sensations of pressure, abdominal heaviness and fullness significantly better than control.8,9 Cisapride, no longer an FDA-approved pro-motility drug after its removal from the market in 2000 due to cardiovascular side effects, was shown to have efficacy similar to a caraway oil/peppermint oil formulation10.

Complete and final results from a real-world, observational study of 600 patients who took FDgard, called FDACT™ (Functional Dyspepsia Adherence and Compliance Trial), were selected after peer review and presented by William D. Chey, M.D., FACG, at the World Congress of Gastroenterology at ACG 2017 in Orlando, Florida. The data showed there was a consistently high level of patient satisfaction and rapid improvement of FD symptoms with the product. A majority of patients (95 percent) reported major or moderate improvement in their overall FD symptoms, while many patients (86.4 percent) indicated experiencing relief from symptoms within 2 hours after taking FDgard. The findings from FDACT substantiate the data reported in FDREST.

The usual adult dose of FDgard is 2 capsules, as needed, up to two times a day, not to exceed six capsules per day. Many physicians are now recommending taking FDgard daily and proactively 30-60 minutes before a meal, as this enables the supportive effect of FDgard to start as early as possible. While FDgard does not require a prescription and is available in retail outlets and online, it is a medical food that should be used under medical supervision.

About IM HealthScience®

IM HealthScience® (IMH) is the innovator of IBgard®and FDgard®for the dietary management of Irritable Bowel Syndrome (IBS) and Functional Dyspepsia (FD or recurring, meal-triggered indigestion), respectively. In 2017, IMH added Fiber Choice®, a line of prebiotic fibers, to its product line via an acquisition. The sister subsidiary of IMH, Physician’s Seal®, also provides REMfresh®,

a well-known continuous release and absorption melatonin (CRA-melatonin™) supplement for sleep.

IMH is a privately held company based in Boca Raton, Florida. It was founded in 2010 by a team of highly experienced pharmaceutical research and development and management executives. The company is dedicated to developing products to address overall health and wellness, especially in digestive health conditions with a high unmet medical need. The IM HealthScience advantage comes from developing products based on its patented, targeted-delivery technologies called Site Specific Targeting (SST). For more information, visit www.imhealthscience.com to learn about the company, or www.IBgard.com,

 www.FDgard.com, www.FiberChoice.com, and www.Remfresh.com.

References

1.        Mahadeva S, Goh KL. Epidemiology of functional dyspepsia. A global perspective. World J Gastroenterol. 2006. doi:10.3748/wjg.v12.i17.2661.

2.        Lacy BE, Weiser KT, Kennedy AT, Crowell MD, Talley NJ. Functional dyspepsia: the economic impact to patients. Aliment Pharmacol Ther. 2013;38(May):170-177. doi:10.1111/apt.12355.

3.        Amato A, Liotta R, Mulè F. Effects of menthol on circular smooth muscle of human colon: Analysis of the mechanism of action. Eur J Pharmacol. 2014. doi:10.1016/j.ejphar.2014.07.018.

4.        Liu B, Fan L, Balakrishna S, Sui A, Moris JB, Jordt S-E. TRPM8 is the Principal Mediator of Menthol-induced Analgesia of Acute and Inflammatory Pain. Pain. 2013;154(10):2169-2177. doi:10.1016/j.pain.2013.06.043.TRPM8.

5.        Juergens U, Stober M, Vetter H. The anti-inflammatory activity of L-menthol compared to mint oil in human monocytes in vitro: a novel perspective for its therapeutic use in inflammatory diseases. Eur J Med Res. 1998;3(12):539-545.

6.        Alhaider A, Al-Mofleh I, Mossa J, Al-Sohaibani M, Rafatullah S, Qureshi S. Effect of Carum carvi on experimentally induced gastric mucosal damage in Wistar albino rats. Int J Pharmacol. 2006;2(3):309-315.

7.        Micklefield G, Jung O, Greving I, May B. Effects of intraduodenal application of peppermint oil (WS 1340) and caraway oil (WS 1520) on gastroduodenal motility in healthy volunteers. Phyther Res. 2003;17:135-140. doi:10.1002/ptr.1089.

8.        May B, Köhler S, Schneider B. Efficacy and tolerability of a fixed combination of peppermint oil and caraway oil in patients suffering from functional dyspepsia. Aliment Pharmacol Ther. 2000;14:1671-1677. doi:10.1046/j.1365-2036.2000.00873.x.

9.        Rich G, Shah A, Koloski N, et al. A randomized placebo-controlled trial on the effects of Menthacarin, a proprietary peppermint- and caraway-oil-preparation, on symptoms and quality of life in patients with functional dyspepsia. Neurogastroenterol Motil. 2017;29(May):e13132. doi:10.1111/nmo.13132.

10.      Madisch A, Heydenreich C, Wieland V, Hufnagel R, Hotz J. Treatment of Functional Dyspepsia with a Fixed Peppermint Oil and Caraway Oil Combination Preparation as Compared to Cisapride – A multicenter, reference-controlled double-blind equivalence study. Arzneimittelforsch Drug Res. 1999;49(II):925-932.

This information is for educational purposes only and is not meant to be a substitute for the advice of a physician or other health care professional. This information should not be used for diagnosing a health problem or disease. While medical foods do not require prior approval by the FDA for marketing, they must comply with regulations. It should not be assumed that medical foods are alternatives for FDA-approved drugs. Only doctors can definitively diagnose functional dyspepsia. Use under medical supervision. The company will strive to keep information current and consistent but may not be able to do so at any specific time. Generally, the most current information can be found on www.fdgard.com. Individual results may vary.

Other related articles were published in this Open Access Online Scientific Journal include the following:

2017

Series D: BioMedicine & Immunology https://pharmaceuticalintelligence.com/biomed-e-books/series-d-e-books-on-biomedicine/

2015

The relationship of stress hypermetabolism to essential protein need

https://pharmaceuticalintelligence.com/2015/10/25/the-relationship-of-stress-hypermetabolism-to-essential-protein-needs/

Liposomes, Lipidomics and Metabolism

https://pharmaceuticalintelligence.com/2015/11/02/liposomes-lipidomics-and-metabolism/

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Innovation + Technology = Good Patient Experience

Reporter: Gail S. Thornton

 

Following are a sampling of several relevant articles comprising health innovation and technology, which may ultimately lead to a good patient experience. 

When a health journalist found out her 4-year-old son had a brain tumor, her family faced an urgent choice: proven but punishing rounds of chemotherapy, or a twice-a-day pill of a new “targeted” therapy with a scant track record.

SOURCE

https://www.reuters.com/investigates/special-report/genomics-tumor/

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Paying for Tumor Testing

A recent U.S. government decision about coverage of tumor sequencing could affect cancer patients.

SOURCE

https://www.cancertodaymag.org/Pages/cancer-talk/Paying-for-Tumor-Testing.aspx

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Dr. Elaine Schattner has authored numerous articles on cancer — as a doctor and patient. She is a freelance journalist and former oncologist who lives in New York City. She is writing a book about public attitudes toward cancer.

A life-long patient with scoliosis and other chronic medical conditions, and a history of breast cancer, Elaine’s current interests include physicians’ health, cancer, and medical journalism.

SOURCE

https://www.elaineschattner.com/

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Speaking Up for Patient Preferences in Cancer Treatment Decisions.

Informed consent should include your input.

SOURCE

https://health.usnews.com/health-news/patient-advice/articles/2016-04-15/speaking-up-for-patient-preferences-in-cancer-treatment-decisions

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Breast Cancer, Risk And Women’s Imperfect Choices

SOURCE

https://www.npr.org/sections/health-shots/2013/05/15/184188710/breast-cancer-risk-and-womens-imperfect-choices

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A cancer researchers takes cancer personally: Dr. Tony Blau, who started All4Cure, an online platform for myeloma clinicians and researchers to interact directly with patients to come up with a customer treatment plan.

SOURCE

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Julia Louis-Dreyfus Acts Out: The actress on challenging comedy’s sexism, fighting cancer, and becoming the star of her own show.

SOURCE

https://www.newyorker.com/magazine/2018/12/17/julia-louis-dreyfus-acts-out

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Thanks to Wendy Lund, CEO of GCI Health (gcihealth.com)  and her team for compiling part of this list. 

Interoperability, patient matching could be fixed by smartphone apps, RAND says: Patients need quality information. A physician at George Washington University School of Medicine and Health Sciences believes that the healthcare community must improve reports by making them more accessible to patients.

SOURCE

https://www.healthcareitnews.com/news/interoperability-patient-matching-could-be-fixed-smartphone-apps-rand-says

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Sometimes Patients Simply Need Other Patients: Finding a support community is also getting easier, through resources like the Database of Patients’ Experiences, which houses videos of patients speaking about their experiences

 

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At These Hotels and Spas, Cancer is No Obstacle to Quality Care: A trend among spas and wellness resorts shows the increasing integration of safe wellness treatment options for cancer patients.

SOURCE

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The National Cancer Research Institute (NCRI) identified top 10 research priorities for people living with cancer to consider to improve treatment and quality of life. 

Reporter: Gail S. Thornton

By 2030 four million people in the UK will be living with the long-term consequences of cancer, but currently there is very little research on the problems they face and how these can be tackled. To help them live better lives, more focused research is needed.

To determine priorities for research that will help people live better with and beyond cancer, NCRI partnered with the James Lind Alliance on a Priority Setting Partnership. The two-year project involved two UK-wide surveys which attracted more than 3500 responses from patients, carers, and health and social care professionals. From these, we identified 26 key questions and distilled these down to 10 top research priorities.

This is the first time that clear research priorities have been identified in this area.

Questions 1 – 10 Questions 11 – 26

SOURCE

https://www.ncri.org.uk/lwbc/

 

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More than half of older Americans have “basic” or “below basic” health literacy. How do you make health care decisions when you don’t even understand what the doctor is saying?

From The New York Times

More than half of older Americans lack the skills to gather and understand medical information. Providers must simplify, researchers say.

Every time her parents pick up a new prescription at a Walgreens in Houston, they follow Duyen Pham-Madden’s standing instructions: Use the iPad she bought for them, log onto FaceTime, hold up the pill bottles for her examination.

Her mother, 79, and father, 77, need numerous medications, but have trouble grasping when and how to take them.

The label may say to take one pill three times a day, but “my dad might take one a day,” said Ms. Pham-Madden, 56, an insurance purchasing agent in Blue Springs, Mo. “Or take three at a time.”

So she interprets the directions for them, also reminding her mother to take the prescribed megadose of vitamin D, for osteoporosis, only weekly, not daily.

Part of their struggle, Ms. Pham-Madden believes, stems from language barriers. The family emigrated from Vietnam in 1975, and while her parents speak and read English, they lack the fluency of native speakers.

But recently, Ms. Pham-Madden said, her father posed a question that anyone grappling with Medicare drug coverage might ask: “What’s the doughnut hole?”

Researchers refer to this type of knowledge as “health literacy,” meaning a person’s ability to obtain and understand the basic information needed to make appropriate health decisions.

Can someone read a pamphlet and then determine how often to undergo a particular medical test? Look at a graph and recognize a normal weight range for her height? Ascertain whether her insurance will cover a certain procedure?

Most American adults — 53 percent — have intermediate health literacy, a national survey found in 2006; they can perform “moderately challenging” activities, like reading denser texts and handling unfamiliar arithmetic.

Just 12 percent rank as “proficient,” the highest category. About a fifth have “basic” health literacy that could cause problems, and 14 percent score “below basic.” Health literacy differs by education level, race, poverty and other factors.

And it varies dramatically by age. While the proportion of adults with intermediate literacy ranges from 53 to 58 percent in other age groups, it falls to 38 percent among those 65 and older. The percentage of older adults with basic or below basic literacy is higher than in any other age group; only 3 percent qualify as proficient.

Why is that? Compared to younger groups, the current generation of “older adults were less likely to go beyond a high school education,” said Jennifer Wolff, a health services researcher at Johns Hopkins University.

Moreover, “as adults age, they’re more likely to experience cognitive impairment,” she pointed out, as well as hearing and vision loss that can affect their comprehension.

Consider the recent experience of a retired 84-year-old teacher. All her life, “she was very detail-oriented” and competent, said her daughter, Deborah Johnson, who lives in Lansing, Mich.

But a neurologist diagnosed mild cognitive impairment last summer and prescribed a drug intended to ameliorate its symptoms. It caused a frightening reaction — personality changes, lethargy, dizziness, sky-high blood pressure.

Ms. Johnson thinks her mother might have overdosed. “She told me she thought, ‘This is going to fix me, and I’ll be O.K. So if I take more pills, I’ll be O.K. faster.’”

Yet health literacy can be particularly crucial for seniors. They’re usually coping with more complicated medical problems, including multiple chronic diseases, an array of drugs, a host of specialists. They have more instructions to decipher, more tests to schedule, more decisions to ponder.

Low health literacy makes those tasks more difficult, with troubling results. Studies indicate that people with low literacy have poorer health at higher cost. They’re less likely to take advantage of preventive tests and immunizations, and more apt to be hospitalized.

It may not help much that future cohorts of older adults will be better educated. “The demands of interacting with the health care system are increasing,” Dr. Wolff said. “Ask any adult child of a parent who’s been hospitalized. The system has gotten increasingly complex.”

That doesn’t mean patients deserve all the blame for misunderstandings and snafus. Rima Rudd, a longtime health literacy researcher at Harvard University, has persistently criticized the communications skills of health institutions and professionals.

“We give people findings and tell them about risk and expect people to make decisions based on those concepts, but we don’t explain them very well,” she said. “Are our forms readable? Are the directions after surgery written coherently? If it’s written in jargon, with confusing words and numbers, you won’t get the gist of it and you won’t get important information.”

A few years ago, Steven Rosen, 64, had spent more than two months at a Chicago hospital after several surgeries. Then a social worker came into his room and told his wife Dorothy, “You have to move him tomorrow to an L.T.A.C.”

“I don’t know what you’re talking about,” Ms. Rosen recalled saying. “What’s an L.T.A.C.?”

Question: Was she demonstrating inadequate health literacy, or should the social worker have clarified that L.T.A.C.s — long-term acute care hospitals — provide more care than nursing homes for very ill patients?

Aware of such issues, health care organizations are scrambling to try to make information more accessible and intelligible, and to help patients of all ages understand an often bewildering environment.

They’re hiring squadrons of care coordinators and navigators (sometimes too many), and redesigning and rewriting pamphlets and forms. They’re teaching medical students to communicate more clearly and to encourage patients’ questions.

They’re turning to technology, like secure websites where both patients and family members can see test results or ask questions.

“It’s not the silver bullet we hoped for,” said Amy Chesser, a health communications researcher at Wichita State University, pointing out that many patients are reluctant to turn to provider websites. But the potential remains.

For now, though, often the primary health literacy navigators for older people are their adult children, most commonly daughters and daughters-in-law.

“In the best of all worlds, she’d just be the daughter,” Dr. Chesser said. “But we need her to serve other roles — being an advocate, asking a lot of questions of the provider, asking where to go for information, talking about second opinions.”

The current cohort of people over 70 grew up in a more patriarchal medical system and asking fewer questions, Dr. Wolff pointed out. Her research shows that while most seniors manage their own health care, about a third prefer to co-manage with family or close friends, or to delegate health matters to family or doctors.

Duyen Pham-Madden plays the co-managerial role from hundreds of miles away, keeping spreadsheets of her parents’ drugs, compiling lists of questions for doctors’ appointments, texting photos to pharmacists when the pills in a refilled prescription look different from the last batch.

She’d probably score well in health literacy, but “sometimes even I get mixed up,” she said.

What’s the Medicare doughnut hole? “I had to look it up,” she said. Once she did, she wondered, “How do they expect seniors to understand this?”

SOURCE

 

 

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  • More than 77 percent of patients in the REMfresh® Patient Reported Outcomes DURation (REMDUR) study reported achieving 6 or more hours of sleep after taking REMfresh®, the first continuous release and absorption melatonin (CRA-melatonin)
  • More than 91 percent experienced improvements in sleep onset, sleep maintenance and total sleep quality, after taking REMfresh® (CRA-melatonin)
  • Post-marketing, patient-reported outcomes data reinforces clinical trial evidence demonstrating the potential of non-prescription REMfresh®, as a new, non-prescription, drug-free hypnotic (sleep) product designed to achieve 7-hour sleep
  • New data confirms previously presented SLEEP 2017 study showing the patented Ion Powered Pump (IPP) technology in REMfresh® helps extend melatonin-targeted sleep maintenance levels in the body from 3.7 hours (with marketed immediate-release melatonin) to 6.7 hours, while mimicking the pattern of the body’s natural melatonin blood levels during the nightly sleep cycle

Real Time Coverage at SLEEP 2018 meeting, Baltimore.

Reporters: Aviva Lev-Ari, PhD, RN, and Gail S. Thornton, MA

BALTIMORE – (June 6, 2018) – A patient-reported outcomes study presented at SLEEP 2018 provides confirmatory real-world evidence of the previously peer-reviewed and presented data showing the 7-hour action of REMfresh®, a new product for sleep. REMfresh® Ion-Powered Melatoninis the first and only, continuous release and absorption melatonin (CRA-melatonin) to mimic the body’s own 7-hour Mesa Wave, the natural pattern of melatonin blood levels during a normal night’s sleep cycle. This induces sleep onset and provides lasting and restorative sleep for up to 7 hours.

This new data shows a correlative relationship between a 7-hour Mesa Wave pharmacokinetic (PK) profile and real-world evidence of improvements in sleep duration, onset, maintenance and sleep quality after taking REMfresh® (CRA-melatonin).

The post-marketing REMfresh® Patient Reported Outcomes DURation (REMDUR) study was presented at SLEEP 2018, the 32nd Annual Meeting of the Associated Professional Sleep Societies (APSS), LLC, a joint partnership of the American Academy of Sleep Medicine (AASM) and the Sleep Research Society (SRS).

 

Brodner and Seiden

Pictured here is David C. Brodner, M.D., and David J. Seiden, M.D., FAASM, after presenting the latest study data which found REMfresh is the first and only continuous release and absorption melatonin™ to mimic the body’s own 7-hour Mesa Wave™.

 

In a sample of 500 patients on REMfresh® (CRA-melatonin) responding to an online survey, 77.6 percent achieved 6 or more hours of sleep compared to 23.6 percent who slept that duration prior to taking REMfresh® (p<.0001). A vast majority of respondents also reported a major or moderate improvement in sleep onset (91.6 percent, p<.0001), sleep maintenance (94.8 percent, p<.0001) and total sleep quality (97.2 percent, p<.0001). More than three-quarters (76.6 percent) of patients indicated they take REMfresh® (CRA-melatonin) nightly. The proportion of patients reporting nightly CRA-melatonin use was significantly greater than the proportion of patients with less than nightly use (p<.0001). Most importantly, over 98 percent of patients reported they were very likely or likely to continue taking REMfresh® (CRA-melatonin) to treat their sleep complaints.

“The real-world evidence reported today in REMDUR provides further confirmation that REMfresh® represents a significant advance in the use of melatonin as a baseline therapy for treating sleep complaints,” said David C. Brodner, M.D., a leading sleep specialist who is Double Board-Certified in Otolaryngology — Head and Neck Surgery and Sleep Medicine, founder and principle Physician at the Center for Sinus, Allergy, and Sleep Wellness, in Palm Beach County, Florida, and Senior Medical Advisor for Physician’s Seal, LLC®.

“REMfresh® Ion-Powered Melatoninhas been shown to be an effective drug-free solution that is now available to the millions of Americans in need of a good night’s sleep, many of whom seek new therapies that will induce sleep and keep them asleep until the morning, without causing residual effects they’ll feel the next day. With its unique delivery system that imitates the body’s own natural sleep pattern, REMfresh® has revolutionized the role of melatonin, when delivered in the CRA form. It is no longer just a treatment for jet lag, but the CRA-melatonin found in REMfresh® has been shown to provide substantial relief to individuals having nightly sleep challenges,” said Dr. Brodner.

The scientifically advanced, patented delivery system in REMfresh® (CRA-melatonin), called Ion Powered Pump (IPP™) technology, replicates the way in which the body naturally releases and absorbs melatonin, unlike conventional melatonin sleep products. Since REMfresh® is not a drug, there is no drug hangover.

Nearly one-third of U.S. adults sleep less than the recommended seven hours daily.[1],[2] Increasing evidence suggests an association between sub-optimal sleep duration and adverse health outcomes including a higher risk of diabetes, hypertension, heart attack, stroke, obesity and depression.[3] A pooled analysis of 16 studies and over one million patients found short sleep duration corresponded with greater risk of morbidity and mortality.[4]

 REMDUR Study Design

The post-marketing REMfresh® Patient Reported Outcomes DURation (REMDUR) study was designed to obtain real-world evidence about patients’ sleep patterns, duration of sleep before and after REMfresh® (CRA-melatonin), daily REMfresh® (CRA-melatonin) use, onset of action, sleep maintenance, quality of sleep, and overall satisfaction with REMfresh® (CRA-melatonin).

Patients with sleep disturbances in the general population who received a sample of CRA-melatonin (REMfresh®) from their physicians were invited to complete a 12-question survey. Survey responses were received from 500 patients.

Confirmation of the REMAKT Clinical Study

REMDUR confirmed clinical trial findings from REMAKT (REM Absorption Kinetics Trial), a U.S.-based randomized, crossover pharmacokinetic (PK) evaluation study in healthy, non-smoking adults that compared REMfresh® (CRA-melatonin) with a market-leading, immediate-release melatonin (IR-melatonin).[5]

The study results, peer-reviewed and presented last year at SLEEP 2017, showed that melatonin levels with REMfresh® (CRA-melatonin) exceeded the targeted sleep maintenance threshold for a median of 6.7 hours, compared with 3.7 hours with the leading IR-melatonin. Conversely, the levels of the market-leading IR-melatonin formulation dramatically increased 23 times greater than the targeted levels of exogenous melatonin for sleep maintenance and had a rapid decline in serum levels that did not allow melatonin levels to be maintained beyond 4 hours.

The REMfresh® (CRA-melatonin) studies build upon the body of evidence from prolonged-release melatonin (PR-M), marketed in Europe, which demonstrated in well-conducted, placebo-controlled studies, statistically significant improvement in sleep quality, morning alertness, sleep latency and quality of life in patients aged 55 years and older compared with placebo. REMfresh® (CRA-melatonin) was designed to overcome the challenges of absorption in the intestines, thereby extending the continual and gradual release pattern of melatonin through the night (known as the Mesa Wave, a flat-topped hill with steep sides). There was a fast time to Cmax, which is anticipated to result in improved sleep onset, while the extended median plateau time to 6.7 hours and rapid fall-off in plasma levels at the end of the Mesa Wave, may help to improve sleep maintenance and morning alertness.

Conventional melatonin products have had challenges at mimicking the profile of a Mesa Wave™. The scientific work behind REMfresh® (CRA-melatonin) sought to overcome these challenges by having the melatonin formulation in a matrix that maintains a patented, solubility-enhancing pH environment to help with the transport to the brush border of the gut and its subsequent absorption.

Designed as a hydrogel matrix tablet, REMfresh® (CRA-melatonin) provides rapid release of the melatonin from the surface of the tablet, as the hydrogel release-controlling matrix is setting up in the acidic environment (pH of 1 to 3.5) in the stomach. As the tablet moves into the higher pH (5.5 to 6.5) environment of the small-intestine, which is above the pKa of melatonin (~4.0), the acidic moiety in the tablet is designed to maintain the pH within the tablet below 4.0 for 7+ hours. The hydrogel matrix, after proper hydration, allows continuous release of the active melatonin and acidic moiety into the lumen of the intestines.

Melatonin: The Body’s Natural Sleep Ingredient

Melatonin is produced by the pineal gland in the brain and is the body’s natural sleep ingredient. Melatonin levels normally begin to rise in the mid-to late evening and remain high for the majority of the night. Levels begin to decline towards early morning, as the body’s wake cycle is triggered. As people age, melatonin levels can drop by as much as 70 percent[6] and their bodies may no longer produce enough melatonin to ensure adequate sleep.

Other available products, such as immediate-release melatonin, help initiate the onset of sleep but are usually unable to sustain prolonged sleep maintenance due to an immediate burst of melatonin, which is quickly degraded due to its relatively short half-life (60 minutes). Absorption in the lower digestive tract is limited by melatonin’s limited ability to be absorbed in a low acidity or neutral pH environment.

Importance of Sleep

Sleep is an essential part of every person’s life. The body requires a certain amount of sleep in order to properly rest, repair and renew itself. Sleep is customarily divided in four different stages, with each stage having a different effect. These four stages are:

N1, N2, deep sleep and REM sleep. The body moves among these four stages several times while asleep. If sleep is disrupted for any reason, a person’s body may not have a chance to properly restore itself, especially if it is struggling to get to the later stages, called deep sleep and REM sleep. Studies have shown that sound and sufficient sleep is important for learning, memory and a healthy immune system. A regular pattern of deep sleep and REM sleep will help a person begin the next day feeling refreshed and ready to go.

About Non-Prescription REMfresh®

REMfresh® (CRA-melatonin) is the first and only, continuous release and absorption formulation of UltraMel® melatonin (available as 2 mg and 5 mg and with a 0.5 mg anticipated in the second half of 2018). UltraMel® melatonin is a high-quality, 99 percent ultra-pure melatonin sourced from Western Europe exclusively for Physician’s Seal®.

REMfresh® (CRA-melatonin) is a dietary supplement and is regulated under the Federal Dietary Supplement Health and Education Act, which does not require pre-approval. Melatonin has been in common use for over two decades and has a well-established profile of safe use by millions of people around the world. As with all supplements, individual results may vary.

REMfresh® (CRA-melatonin) is non-habit forming and does not contain narcotics, hypnotics, barbiturates, sedatives, antihistamines, alcohol or other harsh or additive chemicals. The usual adult recommended dose is 1-2 tablets 30-60 minutes before bedtime. Follow specific dosing instructions found on the back of the box for proper use of supplements.

REMfresh® (CRA-melatonin) is available at Walmart, Rite Aid and CVS/pharmacy. In 2017 REMfresh® was ranked as  the #1 recommended brand for sleep management by sleep doctors[7].

About Physician’s Seal®

Physician’s Seal® is the innovator of REMfresh®, the first and only continuous release and absorption, 99 percent ultra-pure melatonin (CRA-melatonin) that mimics the way the body naturally releases and maintains melatonin over a 7-hour period. Physician’s Seal®, founded in 2015, is a privately held company based in Boca Raton, Florida. It is committed to bringing cutting-edge life science applications to doctors and their patients. For more information, visit www.remfresh.com and connect with us on Facebook and You Tube.

Its sister subsidiary, IM HealthScience® (IMH) is the innovator of IBgard® and FDgard® for the dietary management of Irritable Bowel Syndrome (IBS) and Functional Dyspepsia (FD), respectively. In 2017, IMH added Fiber Choice®, a line of prebiotic fibers, to its product line via an acquisition. IMH® is a privately held company based in Boca Raton, Florida. It was founded in 2010 by a team of highly experienced pharmaceutical research and development and management executives. The company is dedicated to developing products to address overall health and wellness, including conditions with a high unmet medical need, such as digestive health. The IM HealthScience® advantage comes from developing products based on its patented, targeted-delivery technologies called Site Specific Targeting® (SST®). For more information, visit www.imhealthscience.com to learn about the company, or www.IBgard.com,  www.FDgard.com,and www.FiberChoice.com.

This information is for educational purposes only and is not meant to be a substitute for the advice of a physician or other health care professional. You should not use this information for diagnosing a health problem or disease. The company will strive to keep information current and consistent but may not be able to do so at any specific time. Generally, the most current information can be found on www.remfresh.com. Individual results may vary.

Data Presented at SLEEP 2018 Poster Session on Sleep Maintenance/Sleep Quality

Tuesday, June 5, 2018, 5-7pm

  • (Abstract 0419, Poster Board #104) Improvement in Sleep Maintenance and Sleep Quality with Ion Powered Pump Continuous Release and Absorption Melatonin: Results from a Self-Reported Patient Outcomes Study
    • David J. Seiden, M.D., FAASM, David C. Brodner, M.D., Syed M. Shah, Ph.D.

Visit Physician’s Seal® at booth 220 to learn more about REMfresh®.

The abstract is published in an online supplement of the journal, Sleep, which is available at http://www.sleepmeeting.org/docs/default-source/default-document-library/abstractbook2018.pdf?sfvrsn=2

[1] Ford, E.S., Cunningham, T.J., & Croft, J.B. (2015, May 1). Trends in Self-Reported Sleep Duration among US Adults from 1985 to 2012. Sleep, 38(5):829-832. doi: 10.5665/sleep.4684.

[2] Watson, N.F., Badr, M.S., Belenky, G., Bliwise, D.L., Buxton, G.M., Buysse, D.,…Tasali, E. (2015). Joint Consensus Statement of the American Academy of Sleep Medicine and Sleep Research Society on the Recommended Amount of Sleep for a Healthy Adult: Methodology and Discussion. Journal of Clinical Sleep Medicine, 11(8):931-952. doi:10.1176/appi.ajp.158.11.1856.

[3] Colten, H.R., & Altevogt, B.M. (Eds). (2006). Sleep Disorders and Sleep Deprivation: An Unmet Public Health Problem.  Institute of Medicine (US) Committee on Sleep Medicine and Research. Washington, DC: National Academies Press (US). doi: https://doi.org/10.17226/11617.

[4] Cappuccio, F.P., D’Elia, L., Strazzullo, P.,&  Miller, M.A. (2010). Sleep duration and all-cause mortality: a systematic review and meta-analysis of prospective studies. Sleep, 33(5):585-592

[5] For this clinical trial, the head-to-head comparison was with the 5 mg form; a 2 mg form of the comparator was not available.

[6] Zisapel, N. (2010). Melatonin and sleep. The Open Neuroendocrinology Journal, 3: 85-95.

[7] Among primary care physicians with a certification in sleep disorders who recommended a brand of modified-release melatonin. Quintiles IMS ProVoice July-September 2017 survey.

REFERENCE/SOURCE

Physician’s Seal® and REMfresh® (www.remfresh.com)

Dr. David C. Brodner, Center for Sinus, Allergy, and Sleep Wellness (http://www.brodnermd.com/sleep-hygiene.html)

Other related articles published in this Open Access Online Scientific Journal include the following:

2017

Ultra-Pure Melatonin Product Helps Maintain Sleep for Up to 7 Hours

https://pharmaceuticalintelligence.com/2017/06/11/ultra-pure-melatonin-product-helps-maintain-sleep-for-up-to-7-hours/

2016

Sleep Science

Genetic link to sleep and mood disorders

https://pharmaceuticalintelligence.com/2016/02/27/genetic-link-to-sleep-and-mood-disorders/

2015

Sleep quality, amyloid and cognitive decline

https://pharmaceuticalintelligence.com/2015/10/31/sleep-quality-amyloid-and-cognitive-decline/

2013

Day and Night Variation in Melatonin Level affects Plasma Membrane Redox System in Red Blood Cells

https://pharmaceuticalintelligence.com/2013/02/23/httpwww-ncbi-nlm-nih-govpubmed22561555/

 

Read Full Post »


A Rich Tradition of Patient-Focused Care — Richmond University Medical Center, New York’s Leader in Health Care and Medical Education 

Author: Gail S. Thornton, M.A.

Co-Editor: The VOICES of Patients, Hospital CEOs, HealthCare Providers, Caregivers and Families: Personal Experience with Critical Care and Invasive Medical Procedures

 

Richmond University Medical Center (www.RUMSCI.org), an affiliate of The Mount Sinai Hospital and the Icahn School of Medicine, is a 470+ bed health care facility and teaching institution in Staten Island, New York. The hospital is a leader in the areas of acute, medical and surgical care, including emergency care, surgery, minimally invasive laparoscopic and robotic surgery, gastroenterology, cardiology, pediatrics, podiatry, endocrinology, urology, oncology, orthopedics, neonatal intensive care and maternal health. RUMC earned The Joint Commission’s Gold Seal of Approval® for quality and patient safety.

RUMC is a designated Level 1 Trauma Center, a Level 2 Pediatric Trauma Center, a Level 3 Neonatal Intensive Care Unit (NICU), which is the highest level attainable, and a designated Stroke Center, receiving top national recognition from the American Heart Association/American Stroke Association.  Their state-of-the-art Cardiac Catheterization Lab has Percutaneous Coronary Intervention (PCI) capabilities, for elective and emergent procedures in coronary angioplasty that treats obstructive coronary artery disease, including unstable angina, acute myocardial infarction (MI), and multi-vessel coronary artery disease (CAD).

RUMC maintains a Wound Care/Hyperbaric Center and a Sleep Disorder Center on-site at its main campus.  The facility also offers behavioral health services, encompassing both inpatient and outpatient services for children, adolescents and adults, including emergent inpatient and mobile outreach units.  RUMC is the only facility that offers inpatient psychiatric services for adolescents in the community.

In April 2016, RUMC announced its intent to merge with Staten Island Mental Health Society in order to expand its footprint in Staten Island and integrate behavioral health services alongside primary care. As part of New York’s Medicaid reforms, funding is available to incentivize providers to integrate treatment for addiction, mental health issues and developmental disabilities with medical services.

With over 2,500 employees, RUMC is one of the largest employers on Staten Island, New York.

rumcexteriorrumcexterior2rumcinterior

Image SOURCE: Photographs courtesy of Richmond University Medical Center, Staten Island, New York. Interior and exterior photographs of the hospital.

 

Below is my interview with President and Chief Executive Officer Daniel J. Messina, Ph.D., FACHE, LNHA, which occurred in September, 2016.

What has been your greatest achievement?

Dr. Messina: Professionally, my greatest achievement is my current responsibility – to be President and Chief Executive Officer of one of the greatest hospitals with a strong, solid foundation and rich history. I was born in this hospital and raised on Staten Island, so to me, there is no greater gift than to be part of a transformative organization and have the ability to advance the quality of health care on Staten Island.

My parents taught me the value of responsibility and motivation and instilled in me the drive and tenacity to be the best person I could be – for my employees and for my family. I am a highly competitive person, who is goal-oriented, hands-on and inspired by teamwork. I rarely sit behind my desk as I believe my place is alongside my team in making things happen.

As a personal goal, I recently climbed the 20,000-foot Mount Kilimanjaro in Tanzania. It was the experience of a lifetime. I could not have completed this challenge without the support of the guides and porters who helped me and my group along the way. For me, it was a challenge in proving to myself that I could be out of my comfort zone. My group and I hiked hours and hours each day, dodging rocks and scrambling along rock walls with the goal of reaching the summit. In many ways, it takes a village to climb the mountain, relying on each other in the group to get you to the next level.

In many ways, that is how I see my professional day at the hospital, working with a strong team of dedicated medical staff and employees who are focused on one goal, which is to continue our hard work, continue to improve care and continue to move forward to advance life and health care.

The mission of Richmond University Medical Center, an affiliate of The Mount Sinai Hospital and Mount Sinai School of Medicine, serves the ethnically diverse community of Staten Island, New York, by providing patients with a range of services.

How has your collaboration with the Mount Sinai network helped to expand health care delivery and services for patients of Staten Island, New York?

Dr. Messina: Being able to serve our patients year after year continues to be a top priority, so we are constantly improving upon our rich history of 100 years of exceptional patient-focused care given by our medical and surgical health care professionals as well as innovative technologies and programs created by our award-winning hospital team. We have committed medical specialists, passionate employee staff, exceptional Board of Trustees, supportive elected government officials – all who in their own way contributes to providing the highest level of patient care to the more than 500,000 residents of Staten Island, New York.

As a member of the Mount Sinai Health network, we have found ways to work collaboratively with our academic partner to ensure that our patients’ health care needs not only are fully met but also exceeded. This alliance will facilitate the development of a new, Comprehensive Breast and Women’s Healthcare Center. We have leveraged our Breast and Women’s Health Center with our RUMC general surgeons in conjunction with breast imaging, fellowship-trained physicians from Mount Sinai’s Icahn School of Medicine. The physicians who are granted this renowned fellowship interact with our patients and become an active participant in multidisciplinary breast conferences and resident and medical student education. For patients, this means that they have access to the best minds and latest research, therapies and treatment regimens throughout our network.

What makes Richmond University Medical Center and its specialty areas stand out from other hospitals?

Dr. Messina: We bring the highest level of advanced medicine to our patients. For more than 100 years, we have built a rich history of delivering patient-focused care that is unique. Our organization is recognized as a family organization with strong community spirit and family values. We are proud to be a high-technology/high-touch organization of caring professionals that go above and beyond the standard of health care. Our strengths lie in the areas of acute, medical and surgical care, including emergency care, surgery, minimally invasive laparoscopic and robotic surgery, gastroenterology, cardiology, pediatrics, podiatry, endocrinology, urology, oncology, orthopedics, neonatal intensive care and maternal health.

Each year, we embark upon a comprehensive, robust strategic planning process that involves our senior leadership team, clinical chairs, Board of Trustees as well as our medical and surgical staff and hospital employees that looks out three to five years in the future to determine what is best for the patient. We are each committed in our own way to quality patient care and building an even stronger organization.

Some of our achievements are noteworthy:

  • As a New York City Department of Emergency Services designated Level 1 Trauma Center and Level 2 Pediatric Trauma Center, the only Trauma Center dually verified in New York City, we rely on sophisticated equipment so our medical and surgical specialists are prepared to treat severe conditions within minutes.
  • Our Neonatal Intensive Care Unit (NICU) is a designated Level 3 facility, the highest level attainable. The unit delivers 3,000 babies annually and it was recognized as having the lowest mortality rate in the metropolitan area and a survival rate of 99 percent, that exceeds national benchmarks. Our specialists in our pediatric ambulatory services department treat over 10,000 patients annually and our children’s urgent care area records over 23,000 visits annually.
  • Our state-of-the-art, 38,000-square-foot Emergency Department (ED), which will be replaced by an expanded facility and projected to open in 2018, will provide for more focused care, operational efficiency and flexibility for our staff and patient. We also will be better integrated and connected to the entire hospital campus.

Originally designed to serve 22,000 patients each year, the ED is expected to accommodate an increased volume of patients, which is estimated at 70,000 and give our medical specialists the tools they need to provide the best in care for this volume of patients. In a new patient and family-centered space with 49 treatment positions, the new ED will be connected to the existing hospital, close to surgical services, the radiology department and lab services.

Equally as important, the hospital has been strong in the face of natural disasters, especially Hurricane Sandy which occurred a few years ago, and the new ED is being designed with storm resilient and redundant design to minimize impact from severe weather conditions.

In fact, the New York City Council and the Staten Island Borough President have set aside a combined $13.5 million for this $60+ million project and believe in the transformative impact that it will have on emergency care on Staten Island. These local officials believe that Staten Island residents deserve quality, readily accessible health care.

  • Heroin addiction is an epidemic on Staten Island, so we have a number of programs in place at RUMC’s Silberstein Center to provide outpatient treatment, rehabilitation and clinics, along with group therapy sessions, Alcoholics Anonymous meetings and individual therapy sessions.
  • Our new primary care/walk-in facility in the heart of Staten Island borough is operational and there are no appointments required. Patients can visit with one of three physicians or a nurse practitioner. This off-site facility is not located in the hospital complex and is an expansion of our services outside of the hospital walls.
  • We also maintain a Wound Care Center, Pain Management Center and a Sleep Disorder Center at our facility. In fact, we are the only local facility that offers inpatient psychiatric services for adolescents and we are expanding our capacity to meet the needs of the community.

 

RUMC has been awarded a top designation jointly by the American Heart Association and the American Stroke Association. What does that mean to the hospital?

Dr. Messina: This designation makes us proud as the recipient of the American Heart Association/American Stroke Association’s Quality Achievement Award for six consecutive years and its first Elite Plus recognition. This means that we have achieved 85 percent or higher adherence in indicators for two or more consecutive 12-month periods to improve quality of patient care and outcomes for stroke patients.

Our cardiac catheterization lab with Percutaneous Coronary Intervention (PCI) capabilities – the newest facility of its kind on Staten Island — now treats semi-urgent and elective coronary procedures.

For patients, this means that we have a commitment to ensure that stroke patients receive the most appropriate treatment according to nationally recognized, research-based guidelines based on the latest scientific evidence. With a stroke, when time is lost, brain is lost, and this award demonstrates our commitment to ensuring patients receive care based on evidenced-based guidelines. We are dedicated to continually improving the quality of stroke care and this recognition helps us achieve that goal.

Studies have shown that hospitals that consistently follow these quality improvement measures can reduce length of stay and 30-day readmission rates and reduce disparities in care. To qualify for the Elite Plus recognition, we met quality measures developed to reduce the time between the patient’s arrival at the hospital and treatment with the clot-buster tissue plasminogen activator, or tPA, the only drug approved by the U.S. Food and Drug Administration to treat ischemic stroke. If given intravenously in the first three hours after the start of stroke symptoms, tPA has been shown to significantly reduce the effects of stroke and lessen the chance of permanent disability. We earned the award by meeting specific quality achievement measures for the diagnosis and treatment of stroke patients at a set level for a designated period.

According to the American Heart Association/American Stroke Association, stroke is the number five cause of death and a leading cause of adult disability in the United States. On average, someone suffers a stroke every 40 seconds; someone dies of a stroke every four minutes; and 795,000 people suffer a new or recurrent stroke each year.

The values of Richmond University Medical Center are summarized in the acronym, WE CARE (Welcoming Energized Compassion Advocacy Respect Excellence). How is this part of your day-to-day life?

Dr. Messina: For more than 100 years, Richmond University Medical Center has

been building a rich history of exceptional patient-focused care for the residents of Staten Island. Each year, we carry that tradition forward by our medically innovative and patient-focused care and services we offer. It is the passion, creativity and caring of everyone who is part of our ‘hospital team’ that moves the organization to new heights.

The chart below summarizes our credo, the values that guide us every day and help us focus on the care and well-being of the people who come through our doors.

We are welcoming and gracious toward each other, and toward all who come to receive our services.

Personnel are energized for quality, creativity, commitment and teamwork.

Compassion is the way we share deep concern and care toward each person.

Advocacy is our activity that promotes the rights and responsibilities of patients, families and staff, in the hospital setting and in the community.

We show respect by recognizing the basic dignity of every person in all our interactions and in the formulation of policies and procedures.

Excellence is our way of demonstrating that we can always be more and always be better.

 

The Richmond University Medical Center Board is comprised of distinguished leaders of the Staten Island community who are committed to the success of the hospital and to the health of Staten Islanders.

How is this local approach revolutionizing health care for the Staten Island community?

Dr. Messina: The members of our distinguished Board of Trustees, who represent a cross-section of business professionals and community leaders, continue our goal of meeting the needs of our patients and our hospital.

Our Board remains committed to providing solutions for our patients to challenging healthcare issues they face every day and to making a difference in the lives of patients by providing the latest thinking and technology solutions. Our Board Chairperson Kathryn K. Rooney, Esq., and Vice Chairperson Ronald A. Purpora, as well as the other Board members, and even our elected government officials, have a strong connection to Staten Island and we believe it truly ‘takes a village’ to make this organization flourish.

Each year, our Board of Trustees is presented with new opportunities and possibilities for growth and development. That is why their top priority for this past year was approving the construction of a state-of-the-art Emergency Department (ED) as this undertaking will serve both the patients and staff equally. In order to serve the residents of Staten Island properly, the new ED will accommodate an increased number of patients and our medical staff will receive the tools and technology to provide the best in care for our patients.

This past year, we were provided with a $1.5 million gift from the Staten Island Foundation that will go toward the hospital’s capital campaign to construct the new $60 million Emergency Department. We decided to name the RUMC’s Allan Weissglass Pavilion Center for Ambulatory Care, in honor of our long-time community and business leader, who is a founding Board member and Board of Trustees member. Allan Weissglass devoted his time, energy and talent to the success of this hospital over many years.

We are positioning our organization for the future and we continuously build on our strengths, being responsive to the needs of the community. In the past, we saw the patient was the only ‘customer’ of the hospital. Today, that perception is evolving and our ‘customers’ are many.  With the help and support of donors, local foundations, volunteers, staff, and the community, local government officials, we are building a bright future for Richmond University Medical Center.

What is RUMC’s commitment to graduate medical education?

Dr. Messina: Our six Graduate Medical Education (GME) programs in Internal Medicine, Obstetrics and Gynecology, Pediatrics, Psychiatry, and Diagnostic Radiology and Podiatry, signify our commitment to teaching as a cornerstone of our philosophy. Our medical staff are seen as role models for our medical residents and provide quality training, medical education and research capabilities. Our existing medical staff functions as supervising physicians and gives medical residents exposure to specific responsibilities and patient care, as well as scholarly opportunities. One interesting fact is that the doctors we train come back to help treat our patients by using their knowledge and experience to work in our community.

You mentioned that ‘outreach in the community’ as a key factor in the success of the hospital’s mission to enhance the quality of life for residents of Staten Island. What types of activities are under way?

Dr. Messina: Our lifesaving work takes many forms. We are constantly finding new and different ways to engage with our community – to raise awareness and educate on a number of diseases and conditions, and, hopefully move toward better health care. We believe that our patients need to see us outside of a clinical environment, which strengthens our relationship.

For example, over the past year:

  • We sponsored an annual health and wellness expo with the Staten Island Economic Development Corporation that was attended by over 2,000 people to equip the community with knowledge about their health and the local health services available to them.
  • We pioneered an organ donor enrollment day by welcoming 59 visitors and guests who can potentially donate their organs to save lives.
  • We partnered with the New York City Department of Transportation and our own Trauma team to demonstrate and educate the community on car seat safety.
  • Our Dermatologist team took part in the Borough President’s “Back to the Beach” festival by performing skin screenings and distributing sunscreen and information on skin cancer.
  • Our Obstetrics and Gynecology team hosted a baby expo to talk with new mothers and mothers-to-be about services available at the hospital.
  • Our Diabetologist team partnered with the YMCA on a 16-week partnership to curb the diabetes epidemic on Staten Island through information talks and health screenings.
  • We were even present at last year’s Staten Island Yankees home opening baseball game to throw out the first pitch and conduct a blood drive while distributing wellness information.

 

Since roughly one third of the residents on Staten Island are enrolled in Medicaid or Medicare, what steps are you taking to improve the delivery of treatment for them?

Dr. Messina: We started several initiatives last year that were funded by the federal and state governments to look at the way care is delivered to patients who are enrolled in Medicare and Medicaid. So far, we’ve reduced costs by $3.75 million and realized $1.8 million in shared savings that are re-invested in key hospital programs.

As you know, Medicare and Medicaid are two different government-run programs that were created in 1965 in response to the inability of older and low-income Americans to buy private health insurance. They were part of our government’s social commitment to meeting individual health care needs. Medicare is a federal program that provides health coverage if you are 65 or older or have a severe disability, no matter your income, while Medicaid is a state and federal program that provides health coverage if you have a very low income.

We’ve set up our own Richmond Quality Accountable Care Organization (ACO), that comprises 30 providers serving 7,500 Medicare patients. This innovative program is accountable for the quality, cost and overall care provided to people on Medicare and who are enrolled in the traditional fee-for-service program.  One program that is ongoing is one that we’ve partnered with the Visiting Nurse Service of Staten Island to prevent hospital readmissions and to identify hospitalized patients who would benefit from a higher level of care and home care services.

Another program that is under way for our Medicaid patients is teaching our staff to prevent hospital readmissions by creating an accurate list of medications that a patient takes and comparing that list against physician’s admission, transfer and discharge orders to ensure that the correct medication plan is in place.

We believe that we are transforming the underlying systems with a focus on delivering quality care and hopefully better outcomes for patients.

RUMC recently announced a merger with Staten Island Mental Health Society (SIMHS) to integrate SIMHS’ broad range of behavioral health programs into the hospital’s existing medical and behavioral program throughout Staten Island. What does this merger bring to the community?

Dr. Messina: We believe that the proposed merger between RUMC and the Staten Island Mental Health Society (SIMHS) will provide a strengthened, comprehensive network of behavioral health services across Staten Island.

This partnership will bring together two Staten Island institutions, with a combined 230 years of service to the borough, and create one strong and vibrant organization dedicated to meeting the health needs of the diverse community.

Merging the range of community-based behavioral health services provided by SIMHS with the solid foundation of primary care services provided by RUMC will create a seamless range of behavioral and medical services for our residents. We are in the unique position to transform and enhance the services of these two vital health care providers. The SIMHS will keep its name and become a division of the hospital. The merger is expected to close during calendar year 2017.

 rumcdanmessina

Image SOURCE: Photograph of President and Chief Executive Officer Daniel J. Messina, Ph.D., FACHE, LNHA, courtesy of Richmond University Medical Center, Staten Island, New York.

Daniel J. Messina, Ph.D., FACHE, LNHA
President & Chief Executive Officer

Daniel Messina, Ph.D., FACHE, LNHA, became President and Chief Executive Officer of Richmond University Medical Center (RUMC) – an affiliate of The Mount Sinai Hospital and Mount Sinai School of Medicine – in April 2014.

Dr. Messina, a life-long resident of Staten Island, is a seasoned executive with nearly 30 years of healthcare leadership expertise. For the previous 13 years, he served as the System Chief Operating Officer of CentraState Healthcare System in Freehold, New Jersey, where his responsibilities included all System Operations for the Medical Center, Assisted Living Facility, Skilled Nursing and Rehabilitation Center and Continuing Care Retirement Community. While in this role, Dr. Messina developed additional growth strategies that include a new Cancer Center, a Proton Therapy Center, Radio-Surgery, a new Infusion Center and programs in Robotics, Minimally Invasive Surgery, Bariatric and Neurosurgery. Other accomplishments include a new state-of-the-art 26-bed Critical Care Unit, a 49-bed Emergency Department, and the development of an 180,000 sq. ft. Ambulatory Campus and Wellness Center anchored by a 35,000 sq. ft. Medical Fitness Center. Additionally, Dr. Messina developed the Linda E. Cardinale MS Center – one of the largest and most comprehensive MS Centers in the tristate area – leading to a fundraising event that has generated over $2 million.

Dr. Messina received his B.S. in Health Science/Respiratory Therapy from Long Island University Brooklyn, and earned his M.P.A. in Healthcare Administration from LIU Post. He obtained his Ph.D. in Health Sciences and Leadership at Seton Hall University where he currently serves as an adjunct professor in the School of Health and Allied Sciences. He is active in the American College of Health Care Executives, is board certified in healthcare management as an ACHE Fellow, and recently completed a three-year term as Regent for New Jersey.

Dr. Messina serves as trustee on the National Multiple Sclerosis Society, the New Jersey Metro Chapter, and the Alumni Board of Trustees at Seton Hall University. He is a Board member of the VNA Health Group of New Jersey and a member of the Policy Development Committee of the New Jersey Hospital Association. Dr. Messina has been honored by various organizations for his service to the community, including Seton Hall University with the “Many Are One” award, the American College of Healthcare Executives with Senior, Early and Distinguished Service Awards, New Jersey Women Against MS, CentraState Auxiliary, and the Staten Island CYO.

Editor’s note:

We would like to thank William Smith, director of Public Relations, Richmond University Medical Center, for the help and support he provided during this interview.

 

REFERENCE/SOURCE

 

Richmond University Medical Center (http://rumcsi.org/Main/Home.aspx)

Other related articles:

Retrieved from http://rumcsi.org/main/annualreport.aspx

Retrieved from https://en.wikipedia.org/wiki/Richmond_University_Medical_Center

Retrieved from http://rumcsi.org/main/rumcinthenews/si-live-5202016-170.aspx

Retrieved from http://rumcsi.org/main/rumcinthenews/merger-agreement-4132016-159.aspx

Retrieved from http://blog.silive.com/gracelyns_chronicles/2016/06/rumc_receives_presitigious_bab.html

Retrieved from https://www.statnews.com/2016/10/17/vivan-lee-hospitals-utah/

Other related articles were published in this Open Access Online Scientific Journal include the following: 

2016

Risk Factor for Health Systems: High Turnover of Hospital CEOs and Visionary’s Role of Hospitals In 10 Years

https://pharmaceuticalintelligence.com/2013/08/08/risk-factor-for-health-systems-high-turnover-of-hospital-ceos-and-visionarys-role-of-hospitals-in-10-years/

Healthcare conglomeration to access Big Data and lower costs

https://pharmaceuticalintelligence.com/2016/01/13/healthcare-conglomeration-to-access-big-data-and-lower-costs/

A New Standard in Health Care – Farrer Park Hospital, Singapore’s First Fully Integrated Healthcare/Hospitality Complex

https://pharmaceuticalintelligence.com/2016/06/22/a-new-standard-in-health-care-farrer-park-hospital-singapores-first-fully-integrated-healthcarehospitality-complex/

2013

Helping Physicians identify Gene-Drug Interactions for Treatment Decisions: New ‘CLIPMERGE’ program – Personalized Medicine @ The Mount Sinai Medical Center

https://pharmaceuticalintelligence.com/2013/04/15/helping-physicians-identify-gene-drug-interactions-for-treatment-decisions-new-clipmerge-program-personalized-medicine-the-mount-sinai-medical-center/

Nation’s Biobanks: Academic institutions, Research institutes and Hospitals – vary by Collections Size, Types of Specimens and Applications: Regulations are Needed

https://pharmaceuticalintelligence.com/2013/01/26/nations-biobanks-academic-institutions-research-institutes-and-hospitals-vary-by-collections-size-types-of-specimens-and-applications-regulations-are-needed/

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WEGO Health Awards Competition Focuses on Patients

Author: Gail S. Thornton, M.A., PhD(c)

WEGO Health, a network of over 100,000 influential members of the online health community, empowers patients who drive the health care conversation online.

For their annual “health activist” award competition this year, Gail Thornton, was nominated as the editor/author of a series of compelling patient profiles on chronic and invasive medical conditions that are posted on the online scientific journal, Leaders in Pharmaceutical Business Intelligence.

“The story of patients and their health journey is a critical one to tell and I was blessed to have such inspirational, caring people who shared their lives with me,” said Gail Thornton.” Also many thanks to  Aviva Lev-Ari for her vision in creating this series — and for considering me to be part of it all.”

The series also will be part of an e-book, entitled, The VOICES of Patients, Health Care Providers, Care Givers and Families: Personal Experience with Critical Care and Invasive Medical Procedures, Leaders in Pharmaceutical Business Intelligence (LPBI) Group. Here is the link:  https://pharmaceuticalintelligence.com/biomed-e-books/series-e-titles-in-the-strategic-plan-for-2014-1015/2014-the-patients-voice-personal-experience-with-invasive-medical-procedures/

final series E covers volumes 1_4-vol1

 

“Your contribution to the e-Book is very substantial in bringing the LIVE voices of Patients and Health Care Providers to the EAR of the Public at large,” said Aviva Lev-Ari, Ph.D., R.N., on 9/13/2016, Director and Founder, Leaders in Pharmaceutical Business Intelligence (LPBI) Group, Boston.

Also thanks to Gabriela Contreras for suggesting some of these patients.

Please visit the the link below to review Gail’s nomination details and to endorse her!

https://awards.wegohealth.com/nominees/12485

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