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Webinars and Reports

Beckman Coulter Webinar – Fighting the Pandemic through Mass Testing

Webinar-Beckman Coulter Webinar – Fighting the Pandemic through Mass Testing

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The Coronavirus Disease 2019 (COVID-19), caused by the novel coronavirus strain, known as the severe acute respiratory syndrome coronavirus-2 (SARS-CoV-2), emerged in 2019 and in March 11th, 2020 - The WHO declares the novel coronavirus outbreak to be a pandemic. Since that date, hundreds of molecular tests and immunoassays were rapidly developed, even though many others still await clinical validation and approval.

At this time of the pandemic, there is a need for global solidarity towards test access for the rapid detection of patients. This webinar summarizes the role of different diagnostic tests during the current global wave of COVID-19.

Learning Objectives:

  • To review the available molecular and serological tests used in the management of COVID-19.
  • To share a summary of the UAE testing guidelines and recommendations. 
  • To emphasize the role of a fast and accurate antigen test as a solution in battling the spread of COVID-19 when it can be used in different settings as a diagnostic, screening and surveillance tool.

 

Webinars and Reports

Beckman Coulter Webinar – Role of Laboratory Medicine in Diagnosis and Management of COVID-19

Webinar-Beckman Coulter Webinar – Role of Laboratory Medicine in Diagnosis and Management of COVID-19

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In this webinar, Dr Jean-Sebastien Blanchet, PhD, Director, Global Medical and Scientific Affairs, presents the latest evidence on the critical role of laboratory medicine in essential aspects of COVID-19 management and discuss the challenges of development, validation and clinical implementation of key laboratory tests to fight the global COVID-19 pandemic.

By attending this webinar, you'll come away with an enhanced understanding of:

• The key role of laboratory medicine in the management of COVID-19 pandemic.

• The challenges of fast development and clinical implementation of COVID-19 related laboratory tests.

 

Webinars and Reports

Ortho Clinical Diagnostics Webinar – Clinical use of high-sensitivity cardiac troponin and the ESC 0/1h-algorithms

Webinar-Ortho Clinical Diagnostics Webinar – Clinical use of high-sensitivity cardiac troponin and the ESC 0/1h-algorithms

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In this webinar, Dr Jasper Boeddinghaus, Resident in Cardiology at University Hospital Basel, Switzerland, discusses how to clinically validate the novel VITROS hs-Tnl assay and to derive and validate an assay-specific 0/1h-algorithm accordingly to the European Society of Cardiology (ESC) recommendations.

By attending this webinar, you'll come away with an enhanced understanding of:

• The benefits and potential limitations of the 0-1 hour algorithm.

• Overcoming challenges in validating and implementing such an algorithm.

• The hs Cardiac Troponin assays clinical performance with this algorithm observed in studies.

 

Catheters market size set to be worth US$56.5 billion by 2025

Article-Catheters market size set to be worth US$56.5 billion by 2025

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According to a new report published by Polaris Market Research, the global catheters market is anticipated to reach US$56.5 billion by 2025. In 2017, by product type, the cardiovascular catheter segment captures the largest market shares in terms of revenue and hold major share in the market. Regionally, North America accounted for the major share in the catheter market.

Catheters are thin tubes made up of plastic, nylon, polyvinyl chloride (PVC), and silicon rubber. Catheters are majorly used in catheterization while surgical procedures like angioplasty, and neurosurgery. The catheters market is primarily driven by continuous growth in the population suffering from cardiovascular disorders and diabetes. Presently, various countries showed the growth in the number of patients suffering from hypertension and diabetes which is braced by factors such as smoking, drinking and sedentary lifestyle of the population. In addition, favourable reimbursement policies, increasing demand for minimal invasive surgeries, and technologically advanced catheter with high effectiveness by its use would spur the global catheter market during the forecast period. on other hand, the wide application of catheter in various surgeries such as angioplasty would also push this market. The reimbursements by the Medicaid programme that provide approximately 100 catheters per month to add the growth of catheter market in the future.

Cardiovascular catheter market

Cardiovascular catheters hold a major share in the global catheter market. The cardiovascular catheter market is further segmented as PTCA balloon catheters, IVUS catheters, PTA balloon catheters, electrophysiological catheters, and others. The growth of cardiovascular catheters is majorly driven by the increasing incidences of cardiovascular diseases supporting the growth of cardiovascular interventional procedures. While a urological catheter holds the second largest segment with the largest revenue. The factors contributing to the growth of the urological market are continuous technological advancements and increasing prevalence of urological diseases in the coming year.

Geographically, North America holds a dominating position in the global catheter market followed by Europe and the Asia Pacific. The growth in the North America catheter market is driven by the presence of refined health infrastructure, the high volume of catheterization in medical procedures, high healthcare expenditure by the individuals, and high level of patient awareness about the use catheters. Whereas the Asia Pacific is expected to reach remarkable growth owing to the increased penetration rate of these devices in the developing countries, growing technological advancements pertaining the development of new-catheter devices, and improving healthcare expenditure would influence the catheter market in the Asia Pacific during the forecast period.

The leading companies operating in this industry include Johnson & Johnson Inc., Abbott Laboratories, Becton, Dickson and Company, B. Braun Melsungen AG., Medtronic plc., Boston Scientific Corporation, Cook Group Incorporated, Teleflex Incorporated, Cardinal Health Inc., Smiths Medical, Arrow International Inc., Edward Life Science Corporation, and Coloplast.

Key findings from the study suggest products available in the market are continuously concentrating on the technological advancements that will reduce the side effects caused by the use of catheters. The leading companies while developing new products considers factors such as increasing disposable income and untapped market potential. North America is presumed to dominate the global catheter market over the forecast years and Asia Pacific region shows signs of high growth owing to the booming economies of India, and China.

For successful COVID-19 vaccine distribution efforts more must be done to mitigate waste and build public trust in the cold chain

Article-For successful COVID-19 vaccine distribution efforts more must be done to mitigate waste and build public trust in the cold chain

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As news continues to break about successful late-stage COVID-19 vaccine trials, people around the world are gaining hope that the days of lockdowns, social distancing and mask-wearing will eventually be in the rear-view mirror. Yet, optimism that we can put an end to this pandemic when a vaccine hits the market is challenged by the extreme temperature sensitivity and variability of ultra-frozen, frozen, and refrigerated formulations alike.

Distribution challenges being discussed in the public domain (and behind closed doors) distill down to this problem statement:

We must get the COVID-19 vaccine distributed in mass as quickly as possible without breaking the cold chain. More importantly, we (manufacturers, distributors, government officials, healthcare practitioners, vaccine administrators, advocates and recipients) must be confident that the proper (variable) temperature has been sustained through the last mile so that we can be certain at the moment of injection that a viable dose has not been compromised by heat exposure.

So, while most conversations right now seem focused on dissecting the logistical complexity faced by vaccine transporters and central distribution centres, I am most concerned about what is going to happen in that last mile – and you should be too.

We know that temperature excursions could occur during vaccine distribution. But what we really need to know is whether or not they actually do.

While vaccine manufacturers, distributors, government leaders and even non-governmental organisations (NGO) think about what it is going to take to keep temperature-sensitive vaccines stable in transit, equal consideration must be given to how we’re going to keep doses from being thrown away unnecessarily.

In developed regions, such as North America, Europe and Australia, temperature loggers are generally used to monitor cold chain pallets and packages. Vial-level temperature indicators aren't required on individual vaccine units in these areas like they are in Africa, Eastern Europe, India, and other parts of Asia. So, people handling COVID-19 vaccines after those larger units are broken down, delivered to administration sites and then further dispersed for storage or use have no way of knowing if the vaccine has been compromised due to heat exposure.

If you ask me, that’s the real problem that needs to be addressed in the current COVID-19 vaccine distribution strategy.

If even a single dose "feels warm" to the touch or someone thinks it was "probably sitting out too long," there’s a very good chance that the vial is going to be tossed out of an abundance of caution. Those who are extremely risk averse may even decide to throw out the whole batch, assuming it may have been heat compromised. Remember, it may or may not be a licensed healthcare practitioner making these decisions. In many places, volunteers are going to be recruited and trained exclusively to support the COVID-19 vaccination efforts. People don’t want to inadvertently inject someone with a vaccine that may not be effective because it has been exposed to potentially damaging heat during transport and/or storage.

That’s why every person who touches a vaccine vial after production and through administration must be able to determine if heat exposure has occurred before that point in time. Here’s how:

  • When a pallet or package-level temperature logger indicates an excursion, someone should be able to break open that larger unit to confirm if all individual units have been affected and should be taken out of distribution or if it was just the top layer that got too warm because of direct heat exposure during loading and unloading. This is not possible unless every individual vial has a temperature indicator on it.
  • As the vaccine is being unloaded at the administration site, teams should be able to confirm if the dry ice and other proposed transport cooling methods worked or if replacement doses need to be ordered immediately to avoid prolonged delays in community vaccination.
  • When the vaccine is removed from storage containers, and again as it is being prepped, everyone – from the site supervisor to the vaccine administrator and even the patient – should know with confidence that the cold chain was successfully maintained at every touchpoint.

If the decision is ultimately made to throw away some units – amounting to financial waste, a duplicated resource burden and delay in achieving mass vaccination – then we can at least be certain that such action was the result of a confirmed heat excursion, not someone’s “best judgement.”

The key takeaway

If we want to preserve our limited resources and earn the public’s trust in our ability to maintain the COVID-19 vaccine cold chain all the way through the last mile, then we must commit to putting small, cost-effective vaccine vial monitors on each individual vial in the first mile.

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Tony Cecchin

Non-surgical steam treatment for prostate enlargement available for UAE patients

Article-Non-surgical steam treatment for prostate enlargement available for UAE patients

Prostate enlargement is a common problem for men over 50. By age 60, more than 50 per cent of men face this problem and by age 85 the percentage climbs to 90 per cent. Traditionally, patients suffering with prostate enlargement have been receiving treatment through medications or surgery. The TURP procedure to treat the condition takes about an hour and requires a two to three day stay in hospital.

Patients in the UAE will now be offered an innovative steam treatment – the Rezum water vapour procedure. Available at RAK Hospital in the UAE, the non-surgical option relieves benign prostatic hyperplasia (BPH), also known as prostate gland enlargement, and can be conducted as a daycare procedure without the need for hospitalisation. The quick procedure takes only about 10-15 minutes and doesn’t require general anaesthesia.

BPH is an excess growth of prostate tissue that compresses and obstructs the urethra, reducing the flow of urine from the bladder and sometimes blocking it entirely. Symptoms include waking up multiple times during the night to urinate; frequent, urgent, irregular and weak urinary flow; anxiety; challenges with sexual function and limitations on daily activities.

When the bladder is not emptied completely the risk of developing urinary tract infection increases. Other serious problems can also develop over time, including bladder stones, blood in the urine, incontinence and an inability to urinate. In rare cases, bladder or kidney damage can also occur as a consequence.

Procedure

“The new Rezum therapy reduces the risk of associated complications such as bleeding, incontinence and sexual dysfunction and takes 10-15 minutes under local anaesthesia with patients able to go home the same day,” says Dr Dinanath Thakar, Consultant Urologist and Head of Department at RAK Hospital.

“The procedure is to reduce the size of the prostate and not to cut it out, reduces the magnitude of the intervention and hence the complication rate leaving all the associated body tissue around the prostate undisturbed,” he adds.

The water vapour treatment works by delivering very small amounts of steam to the enlarged prostate which damages the cells causing obstruction, reducing the overall size and the associated symptoms.

“The water boils at 100-degree census,” Dr Thakar explains. “The steam has latent heat giving higher temperature causing sterile prostate cell death.”

Calprotectin: A non-invasive biomarker for inflammatory bowel diseases

Article-Calprotectin: A non-invasive biomarker for inflammatory bowel diseases

Faecal calprotectin (FC) is a sensitive marker of intestinal inflammation and is an important test for differentiating chronic inflammatory bowel diseases (IBD) from functional gut disorders such as irritable bowel syndrome (IBS). The FC level correlates with IBD activity and is, therefore, also suitable for monitoring the effectiveness of a treatment regime and for assessing the risk of relapses. Use of this non-invasive test in a routine setting can significantly reduce the total number of endoscopies performed. FC can be measured quickly and efficiently in patient stool samples using ELISA.

IBD versus IBS

Patients with abdominal pain or diarrhoea represent a large proportion of cases for gastroenterologists. The causes of these symptoms include IBD, such as Crohn’s disease (CD) and ulcerative colitis (UC), and functional disorders such as IBS. It is not possible to differentiate between IBD and IBS based on symptoms alone. In order to obtain a definitive diagnosis, the inflammatory status of the intestinal epithelium is investigated using invasive imaging methods such as endoscopy. These procedures are, however, costly and unpleasant for patients. Moreover, more than half of adult and up to 70 per cent of paediatric patients presenting with symptoms suggesting IBD are endoscopically inconspicuous. Measurement of inflammation-associated biomarkers in faeces represents a cost-effective and non-invasive alternative for differentiating inflammatory from non-inflammatory conditions.

Faecal calprotectin in IBD diagnostics

When the gastrointestinal tract is inflamed, neutrophile granulocytes migrate through the intestinal mucosa into the lumen and secrete calprotectin. This stimulates the immune response and has an antimicrobial effect. The calprotectin secreted into the intestinal lumen accumulates in faeces and is released with it. FC can, therefore, be used as a marker for inflammatory processes that affect only the gastrointestinal tract. Its concentration is proportional to the degree of inflammation. FC is more effective for IBD diagnostics than clinical indices and classical serological markers, such as erythrocyte sedimentation rate (ESR), C-reactive protein (CRP) or leukocyte count. Moreover, calprotectin is produced at the start of the disease, and its determination supports the early diagnosis. Measurement of FC is especially suitable for differentiating IBD from IBS. Various studies have shown a sensitivity of 83 to 95 per cent and a specificity of 84 to 91 per cent for differentiating IBD from IBS in adults. In children, the sensitivity is high (98 per cent) at a lower specificity (68 per cent).

An FC concentration of less than 50 µg/g is considered inconspicuous and excludes an inflammatory cause of gastrointestinal complaints with high certainty. Values between 50 and 120 µg/g lie in the borderline range and further monitoring of patients is indicated, for example, by measuring FC again after two to three weeks. When the FC concentration is greater than 120 µg/g, the inflammatory status of the intestinal epithelium should be examined using imaging methods. Using FC levels to select patients for endoscopy can reduce the total number of endoscopies performed by about two-thirds.

FC measurement is especially suitable for children, to circumvent unpleasant and unnecessary endoscopies. In children older than four years, the normal range corresponds to that of adults. In infants under six months, the FC normal values are distinctly higher (median values 218 to 538 µg/g depending on the study) and subsequently decline with increasing age. In cases of IBD in infants, the FC levels nevertheless correlate with the disease severity. However, due to the lack of an established cut-off, the use of the biomarker in children under four is limited.

Disease monitoring

IBD are episodic diseases, with symptomatic phases alternating with periods of remission. The aim of treatment is to reduce inflammation and relieve symptoms. However, there is no cure. Since FC correlates with the inflammatory activity, it is a suitable surrogate marker for assessing the disease activity in IBD patients. A multitude of studies have shown that FC is effective for predicting relapses in IBD patients in drug-induced remission after withdrawal of the medication. The risk of a relapse is proportional to the measured FC value. Long-lasting remission is associated with a low FC concentration (Figure 1). It is advisable to continually monitor the FC level at regular intervals even during remission phases. When the FC value is elevated, further examinations and therapy adjustments are recommended. The normalisation of the FC value correlates with the reduction in the inflammation of the intestinal mucosa (mucosal healing).

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Figure 1: Faecal calprotectin in IBD monitoring

Post-operative prognosis of relapse

Many CD patients require surgery to remove affected intestinal sections. However, up to 80 per cent of patients experience recurrence of inflammation and clinical relapse after ileocoecal resection. High FC levels are associated with ongoing inflammation after surgery and a greater risk of relapse. Thus, FC is also useful as a risk marker for postoperative recurrence. FC has a higher correlation with the probability and severity of a relapse than CRP and the Crohn’s Disease Activity Index (CDAI).

Recommendations in IBD guidelines

Current international guidelines for IBD diagnostics recommend measuring FC in the differential diagnosis of IBD and IBS (Table 1). Moreover, the guidelines highlight the good correlation between the FC concentration and disease activity.

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Table 1: Calprotectin in international guidelines for IBD diagnostics

Fast, reliable measurement

Calprotectin can be measured quickly and efficiently in stool samples using ELISA. The EUROIMMUN Calprotectin ELISA, for example, is based on microplates coated with anti-calprotectin antibodies which are incubated with patient samples. The assay takes just 75 minutes and can be performed manually or automatically.

The preanalytical sample preparation can be reduced to a minimum through the use of special stool dosage tubes. These enable extraction of a defined amount of stool in just one step, circumventing the need for time-consuming manual weighing and extraction of stool samples. After a centrifugation step no further decanting is necessary. The extraction with the stool dosage tube correlates very well with the manual extraction procedure.

The ELISA has a broad measurement range of 1.9 to 2100 µg/g. Calprotectin values below 50 µg/g can be considered as negative. However, each laboratory should establish its own normal values based on its specific ambient conditions.

Evaluation studies

In a clinical study, stool samples from 47 clinically characterised patients with IBD (n=22) or IBS (n=25) were investigated with the Calprotectin ELISA from EUROIMMUN (Figure 2). Excluding samples in the borderline range, the sensitivity of the test amounted to 94.1 per cent and the specificity to 95.5 per cent. Thus, there was a very high correlation between the FC level and the clinical diagnosis.

 

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Figure 2: Faecal calprotectin levels in IBD and non-IBD patients

Differentiation of CD and UC by autoantibody detection

FC enables reliable identification of IBD, but it cannot distinguish between CD and UC. The two forms of IBD can be differentiated by serological determination of disease-specific autoantibodies. Autoantibodies against acinus cells of exocrine pancreas are a reliable marker for CD. They have a high significance due to their organ specificity, disease association and frequently high serum concentration. The target antigens of the autoantibodies are the pancreas antigens rPAg1 (CUZD1) and rPA2 (GP2). Antibodies against Saccharomyces cerevisiae (ASCA) enrich the serological diagnosis of CD by a further specific parameter. Autoantibodies against intestinal goblet cells occur exclusively in UC. Further markers for UC are autoantibodies against DNA-complexed granulocyte antigens (DNA-ANCA), especially DNA-bound lactoferrin.

Antibodies in IBD can be determined by indirect immunofluorescence assays (IFA). Biochip mosaics containing combinations of different IFA substrates allow simultaneous determination of the different antibodies. The substrates encompass intestinal goblet cells, ethanol-fixed granulocytes, lactoferrin-specific granulocytes, lactoferrin-depleted granulocytes, rPAG1- and rPAg2-transfected cells and fungal smears of Saccharomyces cerevisiae. ASCA can also be determined by ELISA. The broad antibody analysis enables a high diagnostic rate for CD and UC.

Summary

Laboratory tests play an important role in the diagnosis of IBD. In recent years, FC has become an established biomarker for differentiating IBD from IBS and for monitoring IBD patients, while serological detection of different antibodies supports the differentiation between CD and UC. Testing for these biomarkers can avoid invasive and painful endoscopies for the patient. In particular, during the diagnostic workup, only patients with elevated FC need to be referred for further invasive tests. In patients with low FC levels, IBD can be virtually excluded. This is especially relevant given the much higher prevalence of IBS (10-20 per cent) compared to IBD (around 0.4 per cent). In IBD patients, FC measurement can guide therapy decision-making without the need for time-consuming and expensive endoscopies. FC is typically high during flare-ups and lower during remission. In the future, it is anticipated that FC will gain in importance for gastroenterological differential diagnostics and patient management.

This article appears in the latest issue of Omnia Health Magazine. Read the full issue online today, covering cybersecurity in healthcare, the ongoing rise of telehealth and much more.  

Tackling eczema in adolescents

Article-Tackling eczema in adolescents

Having Atopic Dermatitis (Eczema) during adolescence can be a daunting experience. This uncomfortable chronic skin disease can put a dampen on a teenager, especially at a time when many of them would rather focus on social interactions, sports, and extracurricular activities rather than put their attention to the constant management needed to control the triggers. The potentially disfiguring illness also incites bullying among a patient’s peers—a reason its effects are sometimes far worse in these teens mentally and emotionally.

It is, therefore, vital for parents and individuals involved to fully understand the knowledge and concerns associated with this disease in order to determine the best ways to help the young patients manage and deal with it as they go about their transitional phase of growth and development.

Atopic dermatitis, a form of eczema, is a chronic inflammatory disease with symptoms often appearing as a rash on the skin. It is caused, in part, by an underlying inflammation in the body that is believed to be driven by an overactive immune system. Moderate-to-severe atopic dermatitis is characterised by intense, persistent itching, skin lesions and skin dryness, cracking, redness, crusting and oozing. Experts point out that eczema isn’t the visual rash that appears – but rather the sensation of itch that the body experiences on and off.

In the UAE, data released by Dubai Health Authority (DHA) in 2016 showed that out of 20,788 patients who have skin-related diseases, 2,953 or 14.2 per cent of the total cases in the country were confirmed as cases of eczema. Initial symptoms appear around the age of five, with as much as 1 out of 4 children expected to experience atopic dermatitis.

Effects on teens

Unchecked atopic dermatitis can have a physical, emotional and psychosocial impact on children and adolescents, causing sleep disturbance, symptoms of anxiety and depression, as well as feelings of isolation.

In the Journal of Allergy & Clinical Immunology, experts believe eczema can greatly influence how an affected child perceives himself, impacting their psychological development and overall quality of life.

Among the psychological effects mentioned in the study are:

  • Impaired emotional development
  • Increased behavioural problems
  • Sleep difficulties, which could interfere with the intellectual and social development of children
  • Frustration on the part of the parents, resulting in lower social functioning, financial strain and reduced overall wellbeing.
  • Embarrassment and anger about their appearance.

The study also added that with increased disease severity comes the greater impairment of quality of life in both social functioning and mental health—evident in both kids suffering from it as well as the parents. The energy to have the extra efforts required to care for the skin is in short supply especially with children wanting to focus more on their social and academic life.

Managing eczema for teens

Teenagers with atopic dermatitis often have a hard time managing the symptoms and flare-ups due to the less supervision from their parents. As a child, the parents were very much hands-on when it came to looking after their skin, but the responsibility now comes on them as they grow on to become adolescents. This is why for parents; it is important to cultivate in these kids a dedicated attitude towards their skin and overall condition. The goal is to allow them to uphold their lives with minimal disruption—including adequate sleep, focus on academics, and normal social interactions. With the correct approach, teens can control their eczema and have an uninterrupted life.

Focus on education

Parents and experts must properly educate their kids suffering from eczema in order to efficiently help them manage the disease and ingrain in them their needed treatment regime. Once the patients are successfully educated, the frequency of symptoms can be reduced, thereby decreasing the emotional and psychological stress to the patient and the family and improving their overall quality of life.

The study published in the Journal of Allergy & Clinical Immunology about the effects of childhood eczema on the quality of life said this can be done through problem-solving, role-play, computer-assisted instruction, short video clips, a checklist for therapy, or booklets.

Psychological interventions

In many cases, eczema often interferes more with mental health than with physical pain. This is why it is important to include psychological interventions so as to manage the disease well among teenagers.

Among these could include relaxation techniques, which teach patients to tense different muscles and then release that tension. There is also the use of imagery associated with calmness, which could stimulate the feeling in their own body; hypnotherapy, which creates a suggestible state for an individual; and caregiver training programmes, where caregivers will record and reward progress.

Another tremendously helpful intervention are therapies that focus on internal processes. These include cognitive behavioural therapy, counselling and family therapy.

Medical intervention

Atopic dermatitis can be persistent and may return over the years, but they can be manageable with the right treatment for your skin.

The following are among some of the recommended treatment methods for eczema. It is important to consult with a doctor first before a patient pursues these approaches:

Creams and ointment – These products may be prescribed by the doctor to control itching and help repair the skin.

Drugs – Oral antibiotics and antibiotic creams are sometimes prescribed for a short time to treat the infection.

Oral drugs – Doctors sometimes recommend taking oral drugs for severe cases in order to control inflammation. However, these cannot be used long term due to potentially serious side effects.

New options for severe cases

Recently, Dr. Khadija Aljefri, a board member at the Emirates Dermatology Society and a lecturer at Dubai Medical College and consulting dermatologist at DermaMed Clinic Dubai and Dr. Anwar Al Hammadi, President of Emirates Dermatology Society, Adjunct Clinical Associate and Professor of Dermatology at MBRU in Dubai and a consulting dermatologist at DermaMed Clinic Dubai tackled an innovative therapy that is seen to significantly help address high unmet medical needs of adults and kids with AD—the Dupilumab –  during the #LivingwithEzcemaNetwork Facebook online session that tackled insights and information surrounding the condition.

According to Al Hammadi, the therapy—developed by Sanofi and Regeneron under a global collaboration agreement—is a first-in-class biologic medicine approved by the European Commission to treat adults with moderate-to-severe atopic dermatitis who are candidates for systemic therapy.

“For severe cases and persistent cases that didn’t respond to conventional therapy, we have what we call the injection of eczema. This is a newly introduced therapy, but it’s been in the market for four years,” he said.

After receiving a fast-track approval by the Ministry of Health and Prevention in 2018, the UAE has been one of the first five countries in the world to make Dupilumab available to patients. The others include North America, Japan, the Netherlands, and Germany.

The treatment includes injecting patients with the drug every two weeks, as per the recommendation of their doctor. It currently serves as a go-to medicine for patients whose bodies are unable to respond to therapy methods along with regular medications. 

References available on request

This article appears in the latest issue of Omnia Health Magazine. Read the full issue online today, covering cybersecurity in healthcare, the ongoing rise of telehealth and much more.  

Every ounce of gold counts

Article-Every ounce of gold counts

We value gold, and we, therefore, transport it and secure it with very high levels of care. When we think of gold being moved, we imagine a specialist, hopefully, an impregnable security truck making sure that every single ounce of this precious substance is delivered.

But, in comparison to many medications routinely given in oncology regimens and in auto-immune therapies, gold is cheap. Gold’s value hardly equates in value to many of the new generation Monoclonal Antibodies and Gene Therapies, either by ‘per ounce’ value or in its societal value and, of course, in its value to the patient. Furthermore, the price of gold has in fact declined by 9.1 per cent in the last 10 years whilst total pharmaceutical expenditure in member countries of the Organization for Economic Cooperation and Development (OECD) has increased by some 30.1 per cent despite overall consumption only increasing by 7.1 per cent in the same period. (Figure 1)

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Figure 1. Medication Price Changes vs. Gold Prices 2010-2018.

This has triggered many healthcare providers to consider economic arrangements where the financial impact attached to the introduction of new therapies is shared between the payer and the medication’s manufacturers in so-called risk-sharing agreements or outcomes-based contracts. This is certainly laudable and follows a fundamental rule of Value-Based Healthcare; to make the most effective and efficient allocation of scarce resources to meet specified goals.

This said once we have these medications available to us, the second rule of Value-Based Healthcare is to obtain the maximum cost-benefit from the treatments and strategies we employ for patient care. This is where technology, speciality materials and education and training of staff enters the arena.

It is logical that these medications with a monetary value far exceeding that of gold should be as carefully and securely stored as any other precious item. This is an area that technology has already had an impact on the management of Controlled Substances. Central pharmacy integrated medication safes that store, track, and monitor the location and withdrawal of narcotics from satellite Automated Dispensing Cabinets and Anaesthesia Stations can also store high-value medications to reduce the risk of their loss or diversion. This kind of set-up can easily also securely accommodate high-value medications (including intravenous products prior to reconstitution) at every part of their journey from central through to served areas to provide seamlessly, facility-wide management of ‘precious’ inventory.

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Gravimetric compounding systems can record preparation steps and track high-value medications through to patient administration.

Reconstitution of high-value oncology medications is a key process as the potential for hugely expensive wastage through incorrect compounding is a consistent risk. Pharmacist-led double-checks of the technicians’ compounding is difficult to manage as the IV prep clean-room is a deliberately isolated environment. Advanced pharmacy systems that allow for remote checking of correct compounding, and which use barcode scanners to check the correct drug for compounding against the electronic prescription, to deliver appropriate manufacturers’ warnings and precautionary advice as a ‘recipe’ for the technician to follow and employ gravimetric systems for dose/dilution checking help reduce this risk significantly. The entire compounding process can be recorded for checking and record-keeping by automated digital photographic capture of all key stages of compounding and of the final product. This technology allows the pharmacist to be outside of the cleanroom, but in-fact maintain a greater oversight of dosing/dilution than is possible with intermittent checks only being made at critical preparation points.

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Many high-value medications require speciality IV administration lines.

The final printed barcode label for high-value chemotherapy created through an advanced compounding solution allows for tracking through connected inventory systems. Storage of the reconstituted product may require temperature control and light-protection. This is best achieved through medical-grade ‘intelligent’ refrigerators that are also integrated into the medication tracking and inventory system and which have distinct secure compartments within.

The reconstituted high-value medication’s barcode label must also include patient details, drug dose and volume and should also include vitally important instructions for administration, including precautions in terms of the IV administration line required for safe, effective and uncorrupted delivery of this high-value and vital medication to the patient.

It is a common misconception that all IV administration lines are the same. They are not. Incorrect administration line selection by the clinician can cause deleterious changes to the active ingredients in the high-value medication being given. Not only is this potentially harmful to the patient as chemical change may take place in the medication upon contact and interaction with administration line material (the creation of peroxides when some medications and parental nutrition products are exposed to light during administration is an example of this) but there may also be a significant loss in the efficacy of the medication and a degrading of its therapeutic value. Not only is this equivalent to incorrect administration of the medication, it is also potentially a waste of the full monetary value of the medication (a medication that we have purchased at a cost greater than that of gold!)

A good example of the absolute need for the correct selection of administration line for a particular medication is that of the Taxol group of chemotherapeutic medications. These medications require low-sorbing lines and 0.2-micron filtration. The most suitable line for these medications is one with an inert polyethylene lined inner surface which does not allow the medication to come into contact with the PVC body of the line and thus avoids the risk of PVC-plasticizers leaching out from the administration line and into the medication, and with an integrated filter close to the patient.

For IV administration of most Monoclonal Antibodies (such as Daratumumab) an in-line, sterile, non-pyrogenic, low protein-binding polyethersulfone (PES) 0.2-micron filter is required.

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High-value medications can be tracked and secured via integrated, controlled entry systems right from the central pharmacy through to patient administration.

Another issue for the giving of all chemotherapy regimens, and one which has a particular resonance with high-value medications especially for paediatric oncology, is ensuring ‘complete dose’. Running infusions down to completely empty the IV administration tubing of the medication can be difficult to manage in a busy oncology ward or outpatient unit, where one nurse is managing several patients. There are several possible solutions for this issue.

So-called ‘short sets’ that allow independent IV channel rate-control over infusions added to primary infusions of maintenance or hydration fluids. A double-channel or multi-channel pump is ideal for this technique.

Solutions at the spike-level of the administration set with self-sealing connections that allow the clinician to ‘unlock’ from a primary bag, ‘lock’ to the medication to be given, complete the infusions and run the medication bag dry whilst avoiding entry of any air into the administration line due to the IV drip chamber being below the lock-unlock unit, and then returning to the main crystalloid infusion being used for primary line flushing and patient hydration. The same lock-unblock unit allows for switching between several different medications during complex regimens.

Microbore sets that minimise the volume of medication left in the tubing, these sets can have residual volumes as small as 6 millilitres and can be cleared with small flushes.

Beyond oncology, up-to-date and comprehensive IV medication compatibility tables are increasingly difficult to source as multiple new products enter the pharmaceutical market each year. Medication incompatibilities have been suggested as a reason for the failure of both peripheral and central venous access catheters in recent studies, and recommendations on the employment of in-line filtering (either 1.2 micron or 0.2 micron, dependent on the medication/fluid being administered) have been given by study authors. Again, this is essentially a patient safety and quality issue but also carries an economic cost, particularly in the case of unscheduled replacement of central or PICC lines.

One common area of confusion for high-value medications, and also for more ‘general use’ IV medications, is the question of light-protection of infusions. A simple example of this is that a medication such as Epinephrine/Adrenaline which has photostability when mixed in Normal Saline, but which becomes photolabile when mixed in Dextrose solutions.

Pharmaceutical manufacturers give guidance on the protection of their products from light exposure during storage and transport, but advice on protection during administration is more difficult to find. Clinicians will, in fact, find more comprehensive information on this subject, and on all the other areas covered here, via the Clinical and Medical Affairs offices of medication management, infusion pump, and disposables manufacturers. Some common examples of the need for speciality lines in oncology regimens are given in Table 1.

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Table 1: Examples of Chemotherapy Agents and Requirements for Specialty IV Administration Lines.

When compared to the cost of even common medications, and in particular to the cost of newly patented high-value medications and to the waste and detriment to quality care that can occur through incorrect storage, tracking, compounding and administration of intravenous medications the Return on Investment from managing and administering these medications with the care that we should naturally give to such precious and expensive items is undoubtedly significant.

This article appears in the latest issue of Omnia Health Magazine. Read the full issue online today, covering cybersecurity in healthcare, the ongoing rise of telehealth and much more.  

Banking on digitalisation in healthcare

Article-Banking on digitalisation in healthcare

The healthcare landscape in the UAE and the wider GCC region has changed drastically compared to a few years ago, not only on the back of COVID-19, but on account of the evolving maturity stage in the segment. While healthcare has grown in importance and been an attractive space for various investors and conglomerates to venture into, its importance and defensiveness have only been underscored by the pandemic.

In an interview with Omnia Health Magazine, Karim Amer, Head of Healthcare and Education, Corporate and Investment Banking Group, Mashreq Bank, discusses investment trends in healthcare in the GCC region. Excerpts:

What kinds of opportunities should one look at when investing in the healthcare sector?

COVID-19 has highlighted several areas of opportunity and catalysed multiple trends, which have been highlighted in detail in our whitepaper, published in May 2020. To name a few, these include:

The need for investment and further development of digital infrastructure and telehealth solutions, to facilitate the shift of primary care delivery away from hospitals.

A greater reliance on domestic manufacturing in equipment and pharmaceuticals space. Till date, roughly only 20-30 per cent of all pharma product consumption in the GCC is manufactured locally. This is expected to grow by a minimum of 10 per cent over the next five years.

Investment in general hospitals have been slowing down and is expected to continue to reduce as a component of healthcare expenditure with the focus shifting to speciality hospitals and establishing centres of excellence for non-communicable diseases and long-term care.

A growing number of M&A transactions that are expected to materialise over the next 12 months, as larger players look to consolidate their positions at possibly more favourable valuation multiples, and smaller players who are still profitable look to monetise and de-risk.

How do healthcare providers create profitable, sustainable financing structures for better access to financing?

Paramount importance and focus should be placed on corporate governance and transparency. In multiple sectors over the past two to three years, serious lapses in Corporate Governance and lack of transparency as well as misrepresentation, have led to some very high-profile cases for major organisations, not only in the UAE and not only in healthcare, but in Europe and South East Asia as well.

This would have a significant adverse effect on both lender and investment appetites, as well as willingness to deploy liquidity into sectors or geographies who have recently shown an overall poor track-record and performance in terms of Corporate Governance and Transparency. Especially now, in today’s unprecedented conditions, the importance of strong corporate governance and transparency simply cannot be overstated.

The healthcare ecosystem is a very complex one with multiple equally important stakeholders including providers, insurers, regulators and of course the patient, not to mention lenders and financiers. Collaboration between the first three stakeholders is crucial to ensure proper, fair and sustainable financing structures can be put in place by lenders, which will in turn help boost investor confidence in the sector and create more avenues to diversify the sources of funding through the debt capital markets and equity capital markets.

It is, of course, key to note that decently leveraged companies who have historically not relied excessively on bank debt alone, but rather on multiple sources of funding and their own decently capitalised balance sheet, have retained access to a cushion of liquidity through standby working capital facilities or revolving committed facilities.

What are the key growth opportunities in the hospital industry in the GCC region?

If we look at the number of hospitals, it has almost doubled across all GCC countries in the last 10 years. In the UAE specifically, there has been a material growth in the number of hospitals to upwards of 150 hospitals today (up from 107 in 2013). However, there remains to be significant gaps in supply though when it comes to speciality and centres of excellence, long term care and rehabilitation. If you look at the statistics, they still show that an average of 70 per cent of total deaths in the GCC are attributed to non-communicable diseases such as diabetes, cardiovascular disease and cancer, thus highlighting the need to shift investments to specialised care and building centres of excellence in non-communicable diseases (cardiovascular diseases, diabetes, oncology). To give that some more perspective, 17 -25 per cent of GCC populations suffer from diabetes.

Based on the above, providers, investors and regulators are all looking towards specialisation and centres of excellence in areas such as cardiology, oncology, diabetes, IVF and long-term care. The key challenge for the GCC region on that front remains the difficulty of attracting and retaining skilled and highly qualified healthcare professionals, which in turn would tempt patients to pay a premium for specialised facilities within the GCC rather than treatment abroad.

Investment in speciality hospitals is expected to show double-digit growth over the next few years and around 45 per cent of the total GCC healthcare expenditure is expected to be realigned to non-hospital delivery models, particularly for primary and long-term care.

COVID-19 has been a disruptive catalyst across every industry. What are some of the key challenges faced by the healthcare industry?

The healthcare sector, in particular, had to face macroeconomic and operational challenges while continuing to operate under extraordinary and unprecedented conditions fighting the outbreak itself.  Revenues and cash flows of healthcare providers had especially suffered a material blow over three months, from March to May, with the national sanitisation campaign and halt of elective procedures.

While both moves were instrumental in fighting the pandemic, they reduced both outpatient and inpatient volumes, albeit there has been material recovery from the months of June onwards. Another key challenge was the supply chain disruption earlier on during the COVID-19 outbreak. The reduced inflow of cash, coupled with the legacy challenge of receivable collection and minimising insurance claim rejections combined, posed a challenge on overall liquidity management for some players, particularly the smaller or less established ones.

One of the key challenges going forward will be driving cost efficiencies as providers seek to preserve healthy margins and liquidity and investment in digital infrastructure and process outsourcing will be a major part in overcoming that.

Karim Amer, Senior Director - Head of Healthcare and Education, Corporate and Investment Banking Group, Mashreq.jpg

Karim Amer
 

COVID-19 has accelerated the shift towards digitisation across different sectors. What sort of changes are we likely to see in the healthcare industry going forward?

With COVID-19, virtual care has been possibly one of the most talked-about and important topics of all. The medtech industry lags behind its larger healthcare peer, the pharmaceutical industry, and has a lot of room to incorporate digital solutions. The four pillars of digital transformation in the medical technologies industry included manufacturing, care delivery digitisation, connected devices, and connected patients. The market for those is expected to be worth US$178.35 billion in 2021 and grow to US$241.81 billion globally by 2024.

In May 2020, we held a webinar with industry experts titled “Healthcare: What is in store beyond COVID-19”, which examined the state of healthcare across GCC – and found that the subject of telehealth has taken the forefront of the discussion, as providers are now looking to offer safe and convenient solutions for patients, at least for primary consultation while at the same time materially improving their own efficiency, as doctors are able to deal with more patients.

In our whitepaper published in the same month, we predicted investments in digital infrastructure in the GCC to double from US$500 million to upwards of US$1 billion and virtual visits to grow four folds by Q4 2020. Studies show that roughly two-thirds of patients in the region would be ready to engage in AI-enabled solutions – a number that is three times higher when you compare it to Europe or the U.S., possibly on the back of the GCC having a predominantly younger and more tech-savvy population.

Based on all of the above, the virtual care market in the GCC is expected to reach a staggering US$6 billion over the next three years, primarily driven by the digital transformation and AI adoption plans in the UAE and Saudi Arabia. Overall, digital infrastructure investment including virtual care, remote patient monitoring and AI is expected to account to at least a third of total healthcare investments between now and the year 2030.

How important are public-private partnership (PPPs) to improve the overall healthcare infrastructure in the GCC region?

Even prior to COVID-19, the GCC region was increasingly looking at alternative models to build, operate and maintain new and existing public facilities delivering health services. PPPs may bring new opportunities for efficiency, mobilisation of private capital and expertise, and even service delivery innovation, especially as they continue to become a more regular component of the policy landscape across sectors, including healthcare.

However, many examples of success with PPP arrangements come from developed markets. In the UK, for example, 85 per cent of all hospital projects since 1997 have been done under the Private Finance Initiative (PFI) programme through which 130 hospitals with an investment of US$22 billion in capital value have demonstrated several tangible benefits such as 15-20 per cent lower construction cost, 10-45 per cent lower lifecycle cost and 60-70 per cent reduction in construction delays.

There are multiple benefits that can be derived from the PPP model when applied correctly based on experiences in most of the developed countries, where the assets have been developed with lower up-front capital requirement, lower project cost, and better-quality infrastructure, and this has been delivered at speed and efficiency that hasn’t been experienced in traditional models. With the COVID-19 pandemic, the need for public-private partnership was further enhanced to cater better to the increased demand in many emerging areas like long term care, home health services, along with the conventional hospital and primary care sectors.

In light of all the above, it is expected that 35 per cent of all hospital projects in the GCC over the next five years would involve the private sector versus the current level of 25 per cent. This is expected to be primarily fuelled by the PPP agendas in the largest two healthcare markets in the region – Saudi Arabia and the UAE.

Lastly, tell us about Mashreq’s role in the healthcare industry?

Mashreq has been one of the active banks in Healthcare for decades. We were amongst the first banks in the region to introduce a completely separate specialized industry vertical within the bank – that is dedicated to Healthcare. As a step towards more in-depth coverage of the healthcare space, Mashreq bank successfully launched our healthcare Knowledge Partnership with Frost & Sullivan, known as Mashreq Healthcare Leaders Forum.  Mashreq Healthcare Leaders Forum is the first bank / FI backed healthcare forum in the Middle East.  It aims to bring together thought leaders from across the Healthcare sector value chain on one platform, aided by insights and research, to discuss ongoing and expected developments in the Healthcare space.  The forum makes Mashreq the first bank in the Middle East with that level of integration into the Healthcare space.

By coupling our sector specialization along with our versatile and comprehensive product offering which includes bespoke solutions devised specifically for the healthcare sector, we aspire to become a strong partner of the healthcare ecosystem in the region, rather than just a regular balance sheet bank or lender.

This article appears in the latest issue of Omnia Health Magazine. Read the full issue online today, covering cybersecurity in healthcare, the ongoing rise of telehealth and much more.