This came after the firm presented its proposal for a grant of permission to conduct a clinical trial titled “A randomized, open-label study to compare pharmacokinetics and safety of Lupin’s Ranibizumab with Lucentis® in patients with neovascular age‐related macular degeneration” as per protocol No. LRP/LUBT010/2022/001; version 1.0 Date: 10.08.2022."

Neovascular age‐related macular degeneration (AMD) is an advanced form of macular degeneration that historically has accounted for the majority of vision loss related to AMD. The presence of choroidal neovascular membrane (CNV) formation is the hallmark feature of neovascular AMD.

Ranibizumab is a recombinant humanized monoclonal antibody and VEGF-A antagonist used for the management of macular edema after retinal vein occlusion, age-related macular degeneration (wet), and diabetic macular edema.

Ranibizumab binds human vascular endothelial growth factor A (VEGF-A) to prevent it binding its receptors, thereby suppressing neovascularization. The mechanism of action of ranibizumab is similar to other VEGF-targeting therapies.

Ranibizumab was initially approved by the FDA in 2006 and by the European Commission (EC) in 2007. It is marketed under the brand names LUCENTIS and SUSVIMO.

BYOOVIZ, a biosimilar of LUCENTIS, was approved by Health Canada in March 2022, making it the first and only biosimilar drug of ranibizumab available in Canada.

At the recent SEC meeting for Ophthalmology held on 22nd February 2023, the expert panel reviewed the proposal presented by the drug major Lupin for conducting the clinical trial titled “A randomized, open-label study to compare pharmacokinetics and safety of Lupin’s Ranibizumab with Lucentis® in patients with neovascular age‐related macular degeneration” as per protocol No. LRP/LUBT010/2022/001; version 1.0 Date: 10.08.2022.

After detailed deliberation, the committee recommended the grant of permission to conduct the study as per the presented protocol.

Also Read:Sun Pharma Gets CDSCO panel nod to manufacture, market antidiabetic FDC drug

Less than two years after opening a state-of-the-art $26 million hospital in Leadville, Colorado, St. Vincent Health nearly ran out of money.

Hospital officials said in early December that without a cash infusion they would be unable to pay their bills or meet payroll by the end of the week.

The eight-bed rural hospital had turned a $2.2 million profit in 2021, but the windfall was largely a mirage. Pandemic relief payments masked problems in the way the hospital billed for services and collected payments.

In 2022, St. Vincent lost nearly $2.3 million. It was at risk of closing and leaving the 7,400 residents of Lake County without a hospital or immediate emergency care. A $480,000 bailout from the county and an advance of more than $1 million from the state kept the doors open and the lights on.

Since 2010, 145 rural hospitals across the U.S. have closed, according to the Cecil G. Sheps Center for Health Services Research at the University of North Carolina. But covid-19 relief measures slowed that trend. Only 10 rural hospitals shut down in 2021 and 2022 combined, after a record 19 in 2020. Two rural hospitals have closed already this year.

Now that those covid funds are gone, many challenges that threatened rural hospitals before the pandemic have resurfaced. Industry analysts warn that rural facilities, like St. Vincent Health, are once again on shaky ground.

Jeffrey Johnson, a partner with the consulting firm Wipfli, said he has been warning hospital boards during audits not to overestimate their financial position coming out of the pandemic.

He said the influx of cash aid gave rural hospital operators a “false sense of reality.”

No rural hospitals have closed in Colorado in the past decade, but 16 are operating in the red, according to Michelle Mills, CEO of the nonprofit Colorado Rural Health Center, the State Office of Rural Health. Last year, Delta County voters saved a rural hospital owned by Delta Health by passing a sales tax ballot measure to help support the facility. And state legislators are fast-tracking a $5 million payment to stabilize Denver Health, an urban safety-net hospital.

John Gardner took over as interim CEO of St. Vincent after the previous CEO resigned last year. He said the hospital’s cash crunch stemmed from decisions to spend covid funds on equipment instead of operating costs.

St. Vincent is classified by Medicare as a critical access hospital, so the federal program reimburses it based on its costs. Medicare advanced payments to hospitals in 2020, but then recouped the money by reducing payments in 2022. St. Vincent had to repay $1.2 million at the same time the hospital faced higher spending, a growing accounts-payable obligation, and falling revenue. The hospital, Gardner said, had mismanaged its billing process, hadn’t updated its prices since 2018, and failed to credential new clinicians with insurance plans.

Meanwhile, the hospital began adding services, including behavioral health, home health and hospice, and genetic testing, which came with high startup costs and additional employees.

“Some businesses the hospital was looking at getting into were beyond the normal menu of critical access hospitals,” Gardner said. “I think they lost their focus. There were just some bad decisions made.”

Once the hospital’s upside-down finances became clear, those services were dropped, and the hospital reduced staffing from 145 employees to 98.

Additionally, St. Vincent had purchased an accounting system designed for hospitals but had trouble getting it to work.

The accounting problems meant the hospital was late completing its 2021 audit and hadn’t provided its board with monthly financial updates. Gardner said the hospital believes it may have underreported its costs to Medicare, and so it is updating its reports in hopes of securing additional revenue.

The hospital also ran into difficulty with equipment it purchased to perform colonoscopies. St. Vincent is believed to be the highest-elevation hospital in the U.S., at more than 10,150 feet, and the equipment used to verify that the scopes weren’t leaking did not work at that altitude.

“We’re peeling the onion, trying to find out what are the things that went wrong and then fixing them, so it’s hopefully a ship that’s running fairly smoothly,” Gardner said.

Soon Gardner will hand off operations to a management company charged with getting the hospital back on track and hiring new leadership. But officials expect it could take two to three years to get the hospital on solid ground.

Some of those challenges are unique to St. Vincent, but many are not. According to the Chartis Center for Rural Health, a consulting and research firm, the average rural hospital operates with a razor-thin 1.8% margin, leaving little room for error.

Rural hospitals operating in states that have expanded Medicaid under the Affordable Care Act, as Colorado did, average a 2.6% margin, but rural hospitals in the 12 non-expansion states have a margin of minus 0.5%.

Chartis calculated that 43% of rural hospitals are operating in the red, down slightly from 45% last year. Michael Topchik, who heads the Chartis Center for Rural Health, said the rate was only 33% 10 years ago.

A hospital should be able to sustain operations with the income from patient care, he said. Additional payments — such as provider relief funds, revenues from tax levies, or other state or federal funds — should be set aside for the capital expenditures needed to keep hospitals up to date.

“That’s not what we see,” Topchik said, adding that hospitals use that supplemental income to pay salaries and keep the lights on.

Bob Morasko, CEO of Heart of the Rockies Regional Medical Center in Salida, said a change in the way Colorado’s Medicaid program pays hospitals has hurt rural facilities.

Several years ago, the program shifted from a cost-based approach, similar to Medicare’s, to one that pays per patient visit. He said a rural hospital has to staff its ER every night with at least a doctor, a nurse, and X-ray and laboratory technicians.

“If you’re paid on an encounter and you have very low volumes, you can’t cover your costs,” he said. “Some nights, you might get only one or two patients.”

Hospitals also struggle to recruit staff to rural areas and often have to pay higher salaries than they can afford. When they can’t recruit, they must pay even higher wages for temporary travel nurses or doctors. And the shift to an encounter-based system, Morasko said, also complicated coding for billing , leading to difficulties in hiring competent billing staff.

On top of that, inflation has meant hospitals pay more for goods and services, said Mills, from the state’s rural health center.

“Critical access hospitals and rural health clinics were established to provide care, not to be a moneymaker in the community,” she said.

Even if rural hospitals manage to stay open, their financial weakness can affect patients in other ways. Chartis found the number of rural hospitals eliminating obstetrics rose from 198 in 2019 to 217 last year, and the number no longer offering chemotherapy grew from 311 to 353.

“These were two we were able to track with large data sets, but it’s across the board,” Topchik said. “You don’t have to close to be weak.”

Back in Leadville, Gardner said financial lifelines thrown to the hospital have stabilized its financial situation for now, and he doesn’t anticipate needing to ask the county or state for more money.

“It gives us the cushion that we need to fix all the other things,” he said. “It’s not perfect, but I see light at the end of the tunnel.”

KHN (Kaiser Health News) is a national newsroom that produces in-depth journalism about health issues. Together with Policy Analysis and Polling, KHN is one of the three major operating programs at KFF (Kaiser Family Foundation). KFF is an endowed nonprofit organization providing information on health issues to the nation.

USE OUR CONTENT

This story can be republished for free (details).

PAHO and Spain sign agreement to strengthen organ donation and transplant in the Americas

Cristina Mitchell

6 Mar 2023

Exercise is the main medicine needed to fight the scourge of Non Communicable Diseases (NCDs) in Barbados and the wider Eastern Caribbean, in addition to good nutrition.

While speaking on Saturday, the day dedicated to celebrating World Obesity Day, medical practitioners recommended how exercise should be used in patient care.

The Exercise is Medicine Initiative is a global movement by the American College of Sports Medicine, which was used to assess physical activity as a vital sign.

Speaking during the relaunch of the Barbados Association of Medical Practitioners (BAMP) ceremony over the weekend and the Exercise is Medicine presentation, Sports Physician and past President of the Barbados Sports Medicine Association Dr Rene Best encouraged doctors to use exercise as a vital sign similar to how they would check a patients’ heart rate or oxygen blood levels

“Physical activity is a vital sign and you should be documenting that. You should write that this person is getting 250 minutes per week of physical activity. That is the sign to show us that there is something to treat because if that number is zero in writing, you will interview them and try to change it,” he said, adding that it is not a difficult process.

He said inactivity was the one true pandemic before COVID-19.

“From 2012 the pandemic was physical inactivity and it is still going on and affecting us today and probably getting even worse,” he said.

Meanwhile Medical Practitioner Dr Kristyn Kirton shared that their recommendation to physicians is to follow the BRIEF system – an acronym for Baseline activity, Readiness for Change and Risk of participation, Intervention for the individual, Exercise prescription or Expert referral and F for Follow Up.

Baseline activity is to attain the vital sign of exercise to see how much the individual is doing.

“If they are doing nothing we need to use this visit to introduce the idea of exercise and if they are doing something we need to encourage them to keep doing so.”

As for Readiness for change and Risk of participation Dr Kirton said that the physician must look to see how ready the patient is to change.

She also encouraged physicans to intervene in monitoring the individual as a part of the BRIEF process.

As for Exercise Prescription or Expert Referral she said that this is all about the FIT principle, which is about Frequency, Intensity, Timing and Type. The frequency principle is how often a person will exercise, how difficult and when they should exercise and the variation of exercise that they should perform.

She also had this bit of advice for physicians:

“Like any other drug, remember to start low, go slow, stay within your limits, go with the patient and physician because if you know you can’t do a squat don’t advise them to do so unless you’re giving them a printout online or referring them to someone who can,” she said.

Also presenting were physiotherapists Sheldon Batemen and Marita Marshall who spoke on “Steps to Positive Systematic Change United Healthcare.”

“We have a big problem in the Caribbean and Barbados starting with our children – one in three children between the ages of 13 and 15 are obese. That speaks volumes. That should tell us a lot. That should shake us up. We need to do something and we need to do something fast,” she said.

While referencing statistics, which indicate that the English speaking Caribbean has the highest prevalence of diabetes, she said that systems must be put in place to do something about the climbing rates. (MR)

The post Exercise is Medicine: Key to Reducing Diabetes and NCDs appeared first on Barbados Today.

Members of the public are invited to come out to a coastal sundown walk from Martins Bay, St John, to Bathsheba, St Joseph, on Saturday, March 11, beginning at 3 p.m.

The walk is being hosted by the Coastal Zone Management Unit (CZMU), as part of activities to mark Coastal Hazard and Earthquake Smart Month, March 1 to 31, celebrated under the theme All Aboard with Coastal Resilience.

The walk is geared towards showcasing the various coastal features along Barbados.  It is also a health and wellness family-oriented event for children ages five and older.

Bus transportation is available from the Warrens Tower II, Warrens, St. Michael car park, from 2:15 p.m. sharp.  Persons desirous of travelling on the buses are encouraged to visit the CZMU office at Warrens Tower II, Warrens, St. Michael, from Monday, March 6, to collect tickets between 9 a.m. and 4 p.m.

Persons attending the walk are encouraged to bring water and wear long sleeves, comfortable shoes and loose clothing.

The post CZMU Coastal Sundown Walk On March 11 appeared first on Barbados Today.

This year's World Kidney Awareness Week is being observed from March 5-11, with World Kidney Day celebrated on March 9 under the theme 'Preparing for the unexpected, supporting the vulnerable!'

To kick-start the week Georgette Lee-Green, a patient care assistant at CRH, told the Jamaica Observer that patients and their loved ones are invited to gather for worship at 9:00 am on Sunday at Salt Spring New Testament Church of God in this western parish. The renal department is looking forward to celebrating its 114 patients during this week.

"The patients and staff will be in attendance. They, the patients and staff, will also be actively involved in the service," Lee-Green said.

Over three days the department will be hosting educational seminars for the relatives and loved ones of those diagnosed with kidney diseases, Lee-Green shared. She explained that with a high prevalence rate of chronic kidney disease across the Jamaica society the CRH renal unit believes that more support is needed for its patients.

"On March 8-10 we will be having a patient education seminar and also a patient appreciation day; the relatives are invited to come in. We will be giving the patients educational talks on their nutrition, a psychologist will be coming in, a pharmacist will be coming, and different churches in the community will be involved in these activities," she told the Sunday Observer.

Lee-Green also noted that a lack of understanding and support had caused several renal patients to feel isolated. Some have also been bullied for their illness, according to the patient care assistant.

"This week is also aimed at educating the public about what renal failure is and what dialysis is, because I don't believe that the public is adequately informed or they even know what it is. Sometimes we have our patients who have a catheter in and are disfigured being teased for it. People who have cancer are supported but I believe that persons who are on dialysis need to be treated fairly just the same," she said.

In addition to that, preventative measures will also be shared during this three-day seminar.

"It is also to sensitise the public on what it is and how to prevent the disease. We know that the two main causes of renal failure are high blood pressure and [elevated] blood sugar. Kidney disease affects everybody. We have patients who are in high school and some who are retired so it affects people of all ages, but it mostly affects people who are diabetic and suffer from high blood pressure," said Lee-Green.

To close the week of celebration the CRH team will be heading to Montego Bay's Sam Sharpe Square on March 11 to host a blood drive.

"We know that renal patients don't produce blood like a healthy person would so sometimes their blood count is low and we have to send them to the blood bank for blood, but there is no blood there. So we saw the dire need for this and we are having a blood drive at Sam Sharpe Square between the hours of 9:00 am and 5:00 pm," she told the Sunday Observer.

The situation at the blood bank, she added, was the sole reason behind the staff's decision to pool their resources together to plan this week of activities.

"This is all funded by the staff. The staff of the renal department pooled their funds together to organise this week for our patients and their loved ones," said Lee-Green.

The patient care assistant further pointed out that the general public's support is critical to the success of their events.

"We would love the public to come out and support our events, especially the blood drive on Saturday, because there are a lot of accidents happening so the blood bank sometimes doesn't have enough blood to supply the victims of these accidents and our renal patients. This is a worthy cause, and people who come out to donate will also be getting a special gift. We also encourage those who have relatives or friends on dialysis to come out to hear how they can be more supportive of their loved ones," she said.

IN our previous article on this topic, we looked at some of the economic issues that serve as a barrier to health care access. Beyond economic issues, there are, however, many issues that limit access and this week we shall look at manpower and geographic issues.

Manpower

Health care delivery depends on human capital to a significant degree despite the increasing use of technology. If there are no doctors, nurses, or ancillary health-care personnel, then there is effectively no health care to access. Jamaica has 0.5 physicians per 1,000 population and 1.8 nurses per 1,000 population (2016 World Bank data). Our Caribbean neighbour Barbados has 2.5 physicians per 1,000 population and 3.1 nurses per 1,000 population. The United States has 2.6 physicians per 1,000 population and 15.7 nurses per 1,000 population. High-income countries on average have 3.7 physicians per 1,000 population compared with 0.3 physicians per population in low-income countries. When we look at specialty care, the gap is much wider and shows why many citizens will unfortunately not have access to speciality care. In the USA, for example, there are 22.3 neurologists per 100,000 population but in Jamaica, we have about 0.0000023 neurologists per 100,000 or 2.3 neurologists per one million. There are 33,701 cardiologists in active practice in the USA resulting in a ratio of about 102 cardiologists per one million population. In Jamaica, we have less than 30 cardiologists in active practice for a population of three million resulting in a ratio of less than 10 cardiologists per million. Many subspecialty areas in neurology, cardiology and other specialities have no representation in the physician pool. Likewise, many of the smaller Caribbean islands have no specialists in many medical fields.

In terms of nurses, high-income countries average 11.4 nurses per 1,000 population when compared with 0.9 nurses per 1,000 population in low-income countries.

While it is sometimes difficult to accurately estimate how many physicians are needed for any one country as this may vary significantly depending on the health, age, and disease burden of a population, the World Health Organization (WHO) recommends one physician per 1,000 population.

It is not difficult to see how manpower shortages affect health care delivery. In our public hospitals and clinics (particularly specialist clinics at our tertiary hospitals) there are long waits both for an appointment to be seen and also long waits during the clinical encounter. Many of our specialists' units which require nurses with advanced qualifications. Intensive-care units (ICUs), labour and delivery wards and operating rooms have critical nursing shortages. In an ICU setting it may very well be that a bed is available for an ill patient but there is no nurse available to deliver care. Operating rooms can sit empty despite physicians who are able to operate because there are no nurses to assist in the operating room or recover the patient after surgery.

These issues are not only noted in the public sector. There are several areas of medicine in the private care arena for which specialists are in relatively short supply or non-existent leading to long waits to see a physician or in some scenarios result in the need to seek care abroad. Interestingly issues of manpower availability are not confined to low-and middle-income countries. The crisis in the National Health Service (NHS) of the United Kingdom is frequently in the news. One of the causes of the failure of health care delivery is a shortage of personnel. The British Medical Association estimates that in their secondary care system there are physician vacancies of 9,053 posts and nursing vacancies of 47,496 posts. Nursing shortages are a problem in most high income countries leading to aggressive recruitment from low and middle income countries which in most cases are unable to compete with the remuneration that is offered.

A manpower issue that is particularly affects low and middle countries is the use of allied health-care practitioners. More developed health care systems have long recognised that much of medical and nursing care is relatively routine and does not require the relatively high cost of physician and nursing labour to deliver. The use of technicians, nursing aides and physician extenders can allow the delivery of health care in a more efficient fashion and to a wider range of individuals. A good example of this is the use of technicians to acquire images for cardiac ultrasound (echocardiography). Echocardiographic images are obtained in a certain sequence, from defined areas for each study. This is standard for every patient. A technician can be trained to do this competently within a few months allowing the cardiologist to spend minutes reviewing the images and reporting vs spending 30 minutes acquiring the images. In the United States the use of technicians for cardiac ultrasound has been routine for more than 30 to 40 years. A technician doing cardiac ultrasound frees the cardiologist to do work for which he is uniquely qualified and which cannot be performed by those with lesser levels of training. The use of midwives for routine delivery is another example. Obstetricians can focus on the delivery of infants that are at high risk for complication or who have problems during labour and delivery. There are, however, many other roles for which allied health-care providers can be useful and generally these are often ignored in health-care systems of low- and middle-income countries.

Geographic distribution of health-care resources

In our previous article we discussed the disparities between countries in terms of access to care but in almost all countries there are significant disparities within countries. These can be seen most easily when comparing the urban rural divide. Globally and within countries, there is significant inequity in the distribution of health-care resources with 80 per cent of resources often accessible to the top 20 per cent of the population in terms of economic position while the bottom 80 per cent have access to 20 per cent of the resources. If we were to think of the distribution of cardiologists in Jamaica. Most of these physicians practice in Kingston, St Andrew, and St Catherine. Mandeville and Montego Bay have probably four cardiologists between them. Aside from outreach clinics, seeing a cardiologist does require travel to one of these areas. Imagine if you live in Portland; then seeking care likely means a day devoted to health care alone. On that day you will not be able to go to work, you may have to think about how do you arrange childcare? If you do not have a car, how will you travel to the hospital or cardiologist's office and at what cost? For many low- and middle-income countries economic opportunities, amenities and quality of life are greater in urban settings, leading both physicians and nurses to gravitate towards those areas leaving rural populations relatively underserved. Globally it is estimated that half of the population lives in rural areas compared with 38 per cent of nurses and 25 per cent of physicians.

This disparity between urban and rural areas is not only a problem of low and middle income countries. In the United States the ratio of primary care physicians to 10,000 population is 39.8/10,000 in rural areas compared to 53.3/10,000 in urban areas. Studies have documented that treatment for heart attack which is time dependent has worse outcomes in the rural United States. Patients in rural areas often have to travel further for care. For example, one study found that patients in need of radiation therapy in rural America needed to travel an average of 40.8 miles when compared with a patient in an urban setting who travelled an average of 15.4 miles. In Europe living in a rural area has been associated with a lack of access to qualified health-care workers, greater distance to major hospitals, less effective emergency care services and greater demands on health-care workers.

In future articles we will address other issues related to health care access.

Dr Ernest Madu, MD, FACC and Dr Paul Edwards, MD, FACC are consultant cardiologists for the Heart Institute of the Caribbean (HIC) and HIC Heart Hospital. HIC is the regional centre of excellence for cardiovascular care in the English-speaking Caribbean and has pioneered a transformation in the way cardiovascular care is delivered in the region. HIC Heart Hospital is registered by the Ministry of Health and Wellness and is the only heart hospital in Jamaica. Send correspondence to info@caribbeanheart.com or call 876-906-2107