Medical Foods Q&A

Enteral nutrition means feeding by way of the gastrointestinal tract. Enteral feeding is indicated when nutrient requirements cannot be met by regular food intake, which can be a consequence of many clinical conditions. Some of the clinical conditions which may require nutritional support via enteral feeding include those that: increase nutritional requirements (e.g. trauma and burns); increase losses (e.g. malabsorption); are associated with poor appetite or nausea (e.g. cancer treatment); make the oral route unviable (e.g. no swallow reflex after a stroke). A functioning - or at least a partially functioning - gut is a prerequisite for enteral feeding.

Enteral nutrition products are regulated as 'food for special medical purposes' (FSMP) defined by European Commission Directive 1999/21/EC which will be replaced by the Delegated Regulation (EU) 2016/128.

FSMPs are one of the food categories governed by the EU Regulation No 609/2013 for Foods for Specific Groups (FSG), which also includes infant and follow-on formulae, baby foods and total diet replacements for weight control. Specific legislation, to supplement the FSG Regulations, has recently been introduced which updates the previous EU directive governing FSMPs; this legislation is found in EU Regulation No 2016/128.

A FSMP is defined within the FSG Regulation as

‘a food specially processed or formulated and intended for the dietary management of patients, including infants, to be used under medical supervision; it is intended for the exclusive or partial feeding of patients with a limited, impaired or disturbed capacity to take, digest, absorb, metabolise or excrete ordinary food or certain nutrients contained therein, or metabolites, or with other medially-determined nutrient requirements, whose dietary management cannot be achieved by modification of the normal diet alone’.

FSMPs are classified into three categories within Regulation No 2016/128:

Category (a) products have been designed for the nutritional management of patients suffering from, or at risk of developing, disease related malnutrition. The patients they are intended for may require a higher intake of a whole range of nutrients than the healthy population.

Patients may have become malnourished through prolonged undernutrition, a reduced ability to absorb nutrients or an increased nutrient requirement due to their disease state. Patients may require intakes of nutrients that are higher than the intakes recommended for normal, healthy individuals in order to correct their nutrient deficiencies and maintain their nutritional status. These products are not specifically manufactured for a particular patient type or disease, but for use by a wide variety of patients, and can be used as a sole source of nourishment or as a supplement to the patient’s diet. Certain oral nutritional supplements (ONS) will fall within the category (a) classification.

Category (b) products are manufactured for specific groups of patients with a particular disease or condition. These patients require a diet that is modified to provide either an increase, or reduction or absence of a specific nutrient, a component of a nutrient, or group of nutrients/components of nutrients. The level of one or more nutrients is modified from the standard formulation levels to reflect the specific requirements of the patient's disease.

These products are specifically designed for use in patients with a specific medical disorder and can be used as a sole source of nourishment or as a supplement to the patient’s diet. Disease-specific ONS will fall within the category (b) classification.

The food referred to in (a) and (b) may also be used as a partial replacement or as a supplement to the patient's diet.

The range of products falling within Category (c) are diverse and include modular supplements and sip feeds which are not designed to replace foods, but to supplement nutrient or energy intakes from the regular diet to meet the patient’s specific nutritional needs. ONS are less likely to fall within this category because it relates to those products which are not designed to be used as the sole source of nutrition.

Category (c) formulations either:

i) do not provide all of the nutrients required by the patient; or

ii) contain all nutrients required, but not in a balance that would allow them to be used as the sole source of nutrition.

Enteral nutrition products are regulated as 'food for special medical purposes' (FSMP) defined by European Commission Directive 1999/21/EC which will be replaced by the Delegated Regulation (EU) 2016/128.

The choice of route will depend on the clinical condition of the patient, their gastrointestinal (GI) function, anatomy and access and expected duration of feeding. Short-term feeding (if there are no contradictions) is typically provided by a naso-gastric tube i.e. a tube that is placed through the nose (or occasionally the mouth, in which case it is called oro-gastric) the tip of which terminates in the stomach past the pylorus.

Longer-term gastric feeding options are gastrostomies (feeding directly into the stomach). These are often placed in endoscopy (i.e. a camera passed into the mouth and down the gastrointestinal tract) and are known as a Percutaneous Endoscopic Gastrostomy (PEG); a Radiological Inserted Gastrostomy (RIG) (a tube inserted into the stomach via x-ray guidance) or a surgical gastrostomy (stomach opened in surgery and a tube inserted) which is now much less common.

Most hospitals will not have a dedicated nutrition support team for enteral nutrition as it is so widespread throughout the hospital. Decisions about tube feeding are generally made in consultation with a clinician, nurse, dietitian and the patient and/or family; the dietitian will decide which feed will be fed and how much is required in order to meet nutritional requirements. A feeding regimen will be provided by the dietitian for nursing staff.

Yes. The development of the Percutaneous Endoscopic Gastrostomy (PEG) technique and the push for care in the community are two factors which have contributed to the increase in Home Enteral Nutrition (HEN). In the UK, a 43% increase in HEN was seen between 2000-2010 although there is evidence of an annual increase of 20-25%.¹

A HEN dietitian may be involved in the ongoing physical, biochemical and anthropometric (measurement of weight, height and possibly body fat) monitoring of patients fed at home.

The provision of enteral nutrition via continuous feeding requires the following equipment:

• Ready to hang bag of feed or feed reservoir;
• Feed pump – ambulatory pumps which are small and lightweight and can be carried in a bag or back pack are available for mobile patients;
• Syringe (for flushing);
• Giving set which attaches from the feed to the tube.

In 2011 an International Standard (ISO 80369-1) was established setting general requirements for small-bore connectors for liquids and gases. This made it virtually impossible for unrelated delivery system units, such as enteral feeding devices and IV lines, to be connected. A new global system of ports and administration set connectors has superseded the ‘purple system’ and is known as ENFit. The connectors were launched in September 2015, and the tubes and enteral syringes were introduced in March 2016. ENFit applies across all enteral nutrition devices and will ensure that only enteral, and not IV, devices can connect together. For more detailed information go to http://stayconnected.org/.

Equipment for parenteral and enteral feeding is provided by preferred suppliers following a procurement exercise. Equipment at home is usually provided by the companies who manufacture enteral nutrition products.

Malnutrition (undernutrition) occurs when the body is not getting enough of the nutrients it needs to stay healthy and can develop if a person stops eating properly, or if the body needs more nutrients than normal (e.g. due to infection). Malnutrition can have an impact on both physical and mental health; symptoms include weight loss, tiredness and a lack of energy.

Malnutrition is a serious problem, with more than three million people in the UK either malnourished or at risk of malnutrition.² Those most at risk of malnutrition are people with chronic diseases, those who have been recently discharged from hospital, people living alone and the elderly. Malnutrition is common in all patient groups and across all age groups, though is most common in older adults. 93% of malnutrition occurs in the community.²

Malnutrition causes a wide range of problems including increased risk of infections, weakness and fatigue, apathy, depression, slow recovery from illness and poor wound healing.

The provision of food and drink and high quality meals is usually the first approach to the prevention of malnutrition unless medical reasons prevent nutritional needs being met by these means alone.

However, an assessment of a patient’s individual circumstances should always be the first step in managing malnutrition. It is important to identify individuals who are already malnourished or at specific risk of malnutrition through nutritional screening, using a validated screening tool (such as the ‘Malnutrition Universal Screening Tool’ – ‘MUST’). Screening should be undertaken in:

• All hospital inpatients – on admission and weekly or when there is a clinical concern
• All hospital outpatients – at first outpatient appointment and where there is a clinical concern
• All residents of care and nursing homes – on admission and repeated monthly given the high prevalence and general frailty of residents (particularly in nursing homes)
• At initial registration in GP surgeries, annually for those aged over 75 years, where there is a clinical concern and at other opportunities such as health checks or vaccinations.

It is also important for health and care staff, including domiciliary care providers, to identify nutritional risk in settings beyond those addressed by NICE including the person’s own home, day centres, extra care and social housing.

Where malnutrition or a risk of malnutrition is detected, a fuller nutritional assessment should be undertaken and this should include identification of the underlying cause of malnutrition, i.e. disease-related malnutrition or non-disease related malnutrition (otherwise known as social malnutrition).

The first step should be to undertake a full assessment of an individual’s risk of malnutrition, including screening with a recognised tool such as 'MUST'. Where the cause of malnutrition is disease-related, individuals may have diminished appetite and/or limited ability to eat and drink. Oral nutritional supplements (ONS) should be considered alongside high quality, energy and nutrient dense food and drink and continued until it is clear that the individual can manage adequate, balanced nutritional intake from ordinary or fortified food and drink alone. For many individuals in hospital, ONS may only be required for one or two days to get them through a period of acute illness, but for others, including individuals in the community, the need may be longer (anything from several weeks to several months).

Oral nutritional supplements (ONS) are ‘Foods for Special Medical Purposes’ (FSMPs). They are specialised nutritional products which contain energy (calories), protein, fat, carbohydrate, vitamins and minerals. They are designed for people who, because of illness or incapacity, are unable to eat enough food to meet their body's daily needs for energy and nutrients. Most ONS are flavoured drinks which are sometimes called 'sip feeds'. ONS are also available as powders that can be made up into drinks, or added to drinks and/or foods like tea, coffee, custard and cereal. There are also some dessert-style or savoury- style ONS. ONS are available in a choice of flavours, styles and textures, so that anyone who needs them is able to find a product that suits them. This helps patients to keep enjoying the products, thereby ensuring that they are adequately nourished.

Standard ONS

Standard ONS are ready made, or powdered, products to help patients meet their nutritional needs. Standard ONS can be used for the majority of patients as recommended by a healthcare professional.

The standard ONS range is available in a variety of options:

• Milkshake Style
• Juice Style
• Dessert Style
• Yogurt Style
• Savoury Style
• Powders that can be made up into drinks or added to drinks or foods such as tea, coffee, custard and cereal.

Specialised ONS

Specialised ONS are ready made or powdered products which are specially formulated to support patients with specific clinical requirements. They should only be used when clinically appropriate, as determined by a healthcare professional: for example:⁴

• High protein ONS: usually for patients with wounds or fractures, post-operative patients, some types of cancer patients, renal patients on dialysis, COPD patients and the elderly
• Fibre-containing ONS: usually for patients who need additional fibre in their diet
• Pre-thickened ONS: for patients with conditions that affect their ability to swallow (dysphagia), such as stroke and neurological conditions
• Small volume, high energy dense ONS: usually for patients who cannot tolerate large volumes of food or drink

Oral nutritional supplements (ONS) are suitable for malnourished patients:

Ø with underlying disease such as cancer, kidney, respiratory or intestinal disease

Ø some surgical patients

• who cannot absorb food adequately from their gut
• who have difficulties with swallowing

Ø and others

• who require high fibre diets
• who require low residue diets (a low residue diet typically contains less than 10 grams of fibre per day)

This list is not exhaustive.

• Oral nutritional supplements (ONS) are typically used in addition to the normal diet, when diet alone is insufficient to meet daily nutritional requirements
• ONS not only increase total energy and protein intake, but also the intake of micronutrients.^5,6 ONS do not reduce intake of normal food⁶
• Evidence from systematic reviews including NICE demonstrate that ONS are a clinically and cost effective way to manage malnutrition particularly amongst those with a low BMI (BMI < 20kg/m²)^6,7
• ONS increase energy and protein intakes, can improve weight and have functional benefits (e.g. improved hand grip strength)^5,6,8,9
• Clinical benefits of ONS include reductions in complications (e.g. pressure ulcers, poor wound healing, infections),^5,6,9 mortality (in acutely ill older people),^5,6 hospital admissions and readmissions.^8,9,10
• Clinical benefits of ONS are often seen with 300-900kcal/day (e.g. 1-3 ONS servings per day) with benefits seen in the community typically with 2-3 months’ supplementation;^5,6,9 however, supplementation periods may be shorter, or longer , according to clinical need.
• Improved quality of life.

Volume has been identified as having an impact on dietary intake and compliance with an oral nutritional supplement (ONS) regimen. Patients can sometimes find it difficult to drink a full bottle of ONS (owing to reduced appetite or early satiety, for example). Increasing the energy density and decreasing the volume of the product can provide patients with the nutrition they need in an easier to manage format. A recent systematic review has shown that, in general, patients finish more of the bottle when they are given more calories per ml and overall, higher energy density ONS are associated with better compliance.¹¹

Historically, ONS in 200ml or 220ml bottles have been the standard ONS of choice. However, recently lower volume (125ml) and/or higher energy density (2.4kcal/ml) products have also become available.

It is generally accepted that offering patients a variety of oral nutritional supplements (ONS) with different sensory characteristics (flavour, texture, appearance, consistency and composition appropriate to each patient’s clinical need) is likely to improve compliance and nutritional intake when compared to a situation where only one type or flavour of ONS is provided. This is particularly important for patients who require nutritional support over an extended period of time when “taste fatigue” can develop.

Variety and alteration in taste (different flavours, temperature and consistency), encouragement and support by staff, as well as administration between meals (and not at meal times) are all important in order to achieve increased energy and nutrient intake with ONS.¹²

In order to boost compliance, it may be beneficial to give patients a choice of flavours. Prescribing more than one flavour option can prevent “taste fatigue”. ONS are available in a comprehensive range of flavours, which may include: vanilla, strawberry, chocolate, mocha, forest fruit, apricot, banana, toffee, neutral, apple, orange, blackcurrant, lemon, tropical fruit, raspberry, peach, peach-mango, caramel, orange, and vanilla-lemon. The savoury flavour options include cream of chicken and cream of tomato. (These flavours are subject to change).

It is true that both milkshakes and oral nutritional supplements (ONS) are available in a variety of sizes and consistencies.

However, the advantage of ONS is that they are uniquely placed to deliver high calorie content and balanced nutrition in a single, easy-to-use, serving. The calorie content of ONS is higher than full-fat milk; ranging from 0.8kcal/ml to 2.4kcal/ml compared to 0.64kcal/ml calories in full fat milk. Also, unlike milk, most ONS provide ~300kcal, 12g of protein and a full range of vitamins and minerals per serving.

It is also important to appreciate that the range of ONS styles available is much wider than milkshakes and includes fruit, yoghurt, pudding and savoury style ONS. ONS are available in liquid, powder and pre-thickened formats and include a variety of types (high protein, fibre containing, low volume), energy densities (1-2.4kcal/ml) and flavours available to suit a wide range of needs.¹³

A dietitian, nurse or doctor may recommend oral nutritional supplements (ONS) if a patient requires extra nutrition to meet their nutritional requirements. Dietitians are highly trained and skilled in identifying, assessing and monitoring patients who are malnourished or at risk of malnutrition, and are able to recommend (or in some cases prescribe) products for patients’ individual clinical conditions, including ONS if appropriate. Unfortunately, however, there are not enough dietitians in practice and many CCGs do not employ them. This can be problematic when CCGs are considering whether to restrict prescriptions of certain products, including ONS. Once a patient has a prescription for ONS, local pharmacies are able to dispense it.

Oral nutritional supplements (ONS) are classed as 'Food for Special Medical Purposes'. They are products that should be used under medical supervision and regularly reviewed. Therefore, although it may be possible for someone to buy ONS over the counter from a pharmacist, we would recommend they seek advice from their healthcare professional first.

The use of oral nutritional supplements (ONS) does not have any negative impact on patients’ appetite or their ability to eat. In fact, a study published in the Journal of Human Nutrition and Dietetics,¹⁴ which looked at elderly patients at risk of malnutrition, found that ONS did not suppress patients’ appetite or their ability to eat normal food. In fact, ONS was shown to significantly increase daily energy intake (food + ONS) and maintain weight.

While eating a nutritious diet is essential to avoid malnutrition, it is not always possible for people to eat enough food, or ingest the nutrients they require, to keep their body healthy.

Oral nutritional supplements (ONS) can partially, or wholly, replace a normal diet to provide patients with the essential nutrients they need when food alone is insufficient to meet their daily nutritional requirements.

Patients requiring ONS range from those with inherited genetic disorders to those with chronic illnesses. These may include cancer, kidney failure, cystic fibrosis, diabetes, difficulties with swallowing, loss of muscle mass and respiratory disease.

ONS can be an essential part of medical management and may be required either for life or for shorter periods of time, for example in patients recovering from a stroke or from surgery. In these cases, they help manage malnutrition, or the risk of malnutrition, until a normal diet can be resumed.

Prescribed when needed, ONS can help manage malnutrition and the associated complications, significantly improving patients’ health outcomes.⁴ They are an evidence based strategy for the management of disease-related malnutrition¹⁵ and are highly regulated.¹⁶

While eating a nutritious diet is essential to avoid malnutrition, it is not always possible for people to eat enough food or ingest the nutrients they require to keep their body healthy. For example, patients recovering from surgery may find it difficult to eat because they cannot swallow or digest food properly or because they have lost their appetite.

The Managing Adult Malnutrition in the Community pathway⁴ clearly indicates that ONS should be used in combination with food as part of the management of malnutrition, which is also referenced in NHS England’s Commissioning Excellent Nutrition and Hydration.¹⁷ It is recommended that this pathway should be followed by healthcare professionals, as a shift away from such treatment could lead to unintended patient outcomes. The provision of oral and enteral nutrition supplements to malnourished patients reduces complications such as infections and wound breakdown by 70% and mortality by 40%.¹⁵

Evidence from a number of systematic reviews and studies, including the National Institute for Health and Clinical Excellence (NICE) guidance on Nutrition Support in Adults (CG32),⁵ and the NICE Quality Standard on Nutrition Support in Adults (QS24),¹⁸ show that ONS are a clinically effective way to manage disease-related malnutrition when food alone, however nutritious, is not sufficient to meet a person’s dietary needs. CG32 states that “oral nutrition support includes any of the following methods to improve nutritional intake: fortified food with protein, carbohydrate and/or fat, plus minerals and vitamins; snacks; oral nutritional supplements; altered meal patterns; the provision of dietary advice.”⁵ Healthcare professionals should ensure that the total nutrient intake of people prescribed nutrition support accounts for energy, protein, fluid, electrolyte, mineral, micronutrients and fibre needs.”⁵ Furthermore, QS24 also advises that care should be taken when fortifying food to supplement energy and/or protein levels to ensure that levels of micronutrients and minerals are also adequately maintained.

A systematic review also demonstrates that there is very little evidence of efficacy of treating malnutrition with food-based strategies alone compared to the use of ONS.¹⁹

In addition, specialist products may be required for people with inborn errors of metabolism, protein sources to avoid a food allergy, problems with absorption or malabsorption of normal foods, or for enteral nutrition administered via nasogastric tube (NGT) or percutaneous endoscopic gastrostomy (PEG). These examples are not exhaustive.

The elderly and institutionalised are thought to be particularly vulnerable to vitamin D deficiency due to their lack of exposure to sunlight and poor dietary intake; this could in turn lead to an increased risk of falls and fractures. Oral nutritional supplements (ONS) will help to meet vitamin requirements in malnourished patients who are unable to meet their dietary requirements, including vitamin D, through food alone.

The NICE Clinical Guideline on Nutrition Support in Adults (CG32) states:

“Oral nutrition support includes any of the following methods to improve nutritional intake: fortified food with protein, carbohydrate and/or fat, plus minerals and vitamins; snacks; oral nutritional supplements; altered meal patterns; the provision of dietary advice.”⁵

It also states: “Healthcare professionals should ensure that the total nutrient intake of people prescribed nutrition support accounts for energy, protein, fluid, electrolyte, mineral, micronutrients and fibre.”⁵

Furthermore, the NICE Quality Standard on Nutrition Support in Adults (QS24),¹⁸ confirms that ONS are a clinically effective way to manage disease-related malnutrition when food alone, however nutritious, is not sufficient to meet a person’s dietary needs: “It is important that nutrition support goes beyond just providing sufficient calories and looks to provide all the relevant nutrients that should be contained in a nutritionally complete diet. A management care plan aims to provide this and identifies condition specific circumstances and associated needs linked to nutrition support requirements.” QS24 also advises that care should be taken when using food fortification which tends to supplement energy and/or protein without sufficient or adequate micronutrients.

Whilst this statement may be true for most people in general terms, it is not always possible for all patients to either access, or to consume, enough nutritious, wholesome foods in practice. It also assumes that all those who are at risk of, or suffering from, malnutrition, should be managed in the same way. Some patients who are not eating enough food (i.e. are undernourished) may be unable to cook or get to the shops; others may be suffering from disease-related malnutrition, for example those who have cancer, cerebral palsy, or have suffered a stroke and have an impaired ability to swallow. In these instances, the use of oral nutritional supplements (ONS) can ensure that patients who need them can receive an adequate intake of energy, proteins, carbohydrates, fats, vitamins, minerals and fibre, which may not be the case with some meals – either because they are not nutritionally balanced or complete, or because the patient cannot eat enough of them to meet their nutritional requirements. In fact a recent randomised control trial concluded that ONS, taken in addition to food, can improve quality of life and nutritional intake more effectively than dietary advice alone.²⁰

Recent statements from some Clinical Commissioning Groups (CCGs) have seemed to suggest that the provision of fortified food is a like-for-like replacement for oral nutritional supplements (ONS). In our view, this approach is over-simplified, does not adequately take into account individuals’ clinical requirements and results in inequity of care for patients whose health outcomes may, as a result, become determined by where they live.

For example, patients living in care homes are thought to be particularly vulnerable to vitamin D deficiency due to their lack of exposure to sunlight and poor dietary intake; this could in turn lead to an increased risk of falls and fractures.²¹ ONS will help to meet vitamin requirements for malnourished patients who are unable to meet their nutritional requirements, including vitamin D, through food alone.

The best approach is to ensure that patients receive appropriate nutritional support, based on their particular circumstances, wherever they are. This would comply both with existing best practice national guidelines and the guiding principle in CCGs’ own constitutions: “access to services based on clinical need”.

The Managing Adult Malnutrition in the Community pathway^4,22 clearly indicates that ONS should be used in combination with food as part of the management of malnutrition, which is also referenced in the recently launched NHS England Commissioning Excellent Nutrition and Hydration.¹⁷ A shift away from such management could lead to unintended patient outcomes. For example, the provision of oral and enteral nutrition supplements to malnourished patients reduces complications such as infections and wound breakdown by 70% and mortality by 40%.¹⁵

While eating a nutritious diet is essential to avoid malnutrition, it is not always possible for people to eat enough food, or ingest the nutrients they require to keep their body healthy, particularly if they are living with a long-term condition or illness.

Oral nutritional supplements (ONS) can partially supplement, or wholly replace, a normal diet to provide patients with the essential nutrients they need when food alone is insufficient to meet their daily nutritional requirements.

Patients requiring ONS range from those who are critically ill to those with inherited genetic disorders to those with chronic illnesses. These may include cancer, kidney failure, cystic fibrosis, diabetes, difficulties with swallowing, loss of muscle mass and respiratory disease.

ONS can be an essential part of medical management and may be required either for life or for short periods of time, for example in patients recovering from a stroke or from surgery. In these cases, they help to manage malnutrition, or the risk of malnutrition, until a normal diet can be resumed.

Prescribed when needed, ONS help to manage the associated complications, significantly improving patients’ health outcomes.⁴ They are an evidence based strategy for the management of disease-related malnutrition¹⁵ and are highly regulated.¹⁶

Two recent systematic reviews published by Professor Marinos Elia and colleagues also highlight the cost-effectiveness of using ONS to support individuals at risk of malnutrition, both in hospital and in the community.^23,24,25

Implementing NICE CG32 and QS24 in 85% of patients with medium and high risk of malnutrition would lead to a net saving of £172.2 - £229.2 million, which equates to £324,800 - £432,300 per 100,000 people.²⁶

NICE has calculated that the delivery of better nutritional care could be the fifth largest potential cost saving available to the NHS.²⁷

According to estimates from Public Health England, two thirds of adults and a quarter of children between two and 10 years old are overweight or obese.²⁸ By 2034, 70% of adults are expected to be overweight or obese.²⁸ Obesity is associated with a range of health problems including type 2 diabetes, cardiovascular disease and cancer. The resulting NHS costs attributable to overweight and obesity are projected to reach £9.7 billion by 2050,²⁸ with wider costs to society estimated to reach £49.9 billion per year.²⁹

In comparison, it is important to note that the health and social care costs associated with malnutrition are estimated to amount to £19.6 billion per year in England alone²⁶ or more than 15% of the total public expenditure on health and social care.²⁶ About half of this is expenditure is accounted for by older people (>65 years) and the other half to younger adults and children. Significant cost savings can be achieved through the provision of nutritional support to people at risk of malnourishment and these savings can be achieved relatively quickly. This has been recognised by NICE in its guidance on cost savings.¹⁸

Correctly assessing patients’ risk of malnutrition should be an integral (not additional) part of all pathways of care.

When CCGs are looking to reduce their overall expenditure on medicines, it is important to look at the burden of malnutrition in the local health economy in terms of healthcare use, hospital admissions and readmissions and patient outcomes, and not just to consider the cost of oral nutritional supplements (ONS). We believe that nutritional support, including ONS, plays a valid, and very important, role in patient care, which has been shown to provide significant clinical and health economic benefits. However, patients should only be prescribed ONS when they cannot meet their daily nutritional requirements from food alone, or are at risk of malnutrition due to a disease, disorder, medical condition or surgical intervention. For example, patients recovering from surgery, those with cancer or those who have had a stroke may find it difficult to eat because they cannot swallow or digest food properly or because they have lost their appetite. If this is the case, they may need ONS to support their recovery and avoid becoming malnourished. Patients who have been clinically screened, and whose treatment plans recommend or require the use of ONS, should have equity of access to available care.

We ask that a prescribing policy supports the appropriate use of ONS under the supervision of a healthcare professional who will be able to decide whether food and/or ONS is the most effective management option for individual patients, taking into account their particular circumstances.

Yes, when prescribed by a healthcare professional and used when needed, after screening and under regular supervision and review. Significant cost savings can be achieved through the provision of nutritional support to people at risk of being malnourished and these savings can be achieved relatively quickly, thus avoiding secondary treatment and costs, as well as higher re-admission rates. This has been recognised by NICE in its guidance on cost savings.¹⁸ The recent British Association for Parenteral and Enteral Nutrition (BAPEN) and the National Institute for Health Research Southampton Biomedical Research Centre (NIHR) report²⁶ states that it costs 3 times more to treat or manage a malnourished patient compared to one without malnutrition, equating to an additional £5,329 per patient. The single most important variable affecting the net cost balance was the cost saving due to the effect of oral nutritional supplements (ONS) in reducing the length of hospital stay. In short, reduced use of healthcare resources due to ONS use could save the NHS £101.8 million every year.²⁶

Furthermore, a recently published systematic review demonstrates that there is very little evidence of efficacy of treating malnutrition with food-based strategies alone compared to the use of ONS.¹⁹ A number of favourable clinical outcomes were also associated with use of ONS, including improved quality of life, reduced minor post-operative complications, reduced infections and reduced falls.¹⁹ Other studies also highlight the cost-effectiveness of ONS in treating malnutrition.^23,24,25 A systematic review of the cost and cost effectiveness of using standard ONS in community and care home settings found that cost-savings were demonstrated for short-term use of ONS (up to 3 months), with a median cost saving of 9.2% (P<0.01). Studies investigating cost savings for the use of ONS for 3 months or more found a median cost saving of around 5%.²⁴

Studies have found that it costs the NHS more NOT to treat malnutrition than to treat it. The recent British Association for Parenteral and Enteral Nutrition (BAPEN) and the National Institute for Health Research Southampton Biomedical Research Centre (NIHR) report²⁶ states that it costs 3 times more to treat or manage a malnourished patient compared to one without malnutrition, equating to £5,329 per patient. The single most important variable affecting the net cost balance was the cost saving due to the effect of ONS in reducing the length of hospital stay. In short, reduced use of healthcare resources due to ONS use could save the NHS £101.8 million every year.²⁶

Malnutrition is currently estimated to cost the NHS £19.6 billion per year in England alone.²⁶ Improving nutritional care for individuals who are malnourished or at risk of malnutrition in hospitals and care homes could therefore have considerable cost-saving implications, including:

• fewer hospital admissions and readmissions
• shorter length of stay in hospital
• fewer healthcare needs in the community (such as GP visits and care at home)

Importantly, the benefits of tackling malnutrition can be realised quickly if patients are prescribed ONS as soon as they need nutritional support. This has been recognised by NICE in its guidance on Nutrition support in adults⁵ (CG32) and the Quality Standard on Nutrition support in adults¹⁸ (QS24).

We too are concerned about waste and would always recommend that oral nutritional supplements (ONS) are prescribed only when needed and coupled with regular monitoring and review of patients’ needs by a healthcare professional as outlined in NICE CG32, NICE QS24 and the Managing Adult Malnutrition in the Community Pathway. However it is worth noting that if care homes fully implemented NICE CG32 – screening those who may be at risk of malnutrition, having the right care pathways in place based on an individual’s malnutrition risk score, conducting regular monitoring and review – they would ensure that only those who need ONS support actually receive it.

The provision of nutritional support to people at risk of being malnourished can achieve significant cost savings. Moreover, these savings can be realised relatively quickly, ensuring that individuals who are malnourished, or at risk of malnutrition, are treated appropriately and in a timely manner, thus avoiding secondary treatment and costs, as well as higher re-admission rates. This has been recognised by NICE in its guidance on cost savings.¹⁸ Other studies also highlight the cost-effectiveness of ONS in treating malnutrition.^23,24,25 A systematic review of the cost and cost effectiveness of using standard ONS in community and care home settings found that cost-savings were demonstrated for short-term use of ONS (up to 3 months), with a median cost saving of 9.2% (P<0.01). Studies investigating cost savings for the use of ONS for 3 months or more found a median cost saving of around 5%.²⁴

Moreover, the recent British Association for Parenteral and Enteral Nutrition (BAPEN) and the National Institute for Health Research Southampton Biomedical Research Centre (NIHR) report²⁶ states that it costs 3 times more to treat or manage a malnourished patient compared to one without malnutrition, equating to an additional £5,329 per patient. The single most important variable affecting the net cost balance was the cost saving due to the effect of ONS in reducing the length of hospital stay. In short, reduced use of healthcare resources due to ONS use could save the NHS £101.8 million per annum.

Patients should only be prescribed oral nutritional supplements (ONS) when they cannot meet their daily nutritional requirements from food alone, and following screening have been found to be at risk of malnutrition, due to surgical intervention or a disease, disorder or medical condition.⁴ Healthcare professionals are best placed to evaluate whether patients need ONS and if so, for how long patients should be taking them. Patients who take ONS should be regularly monitored and reviewed and ONS should be discontinued when an individual is no longer malnourished, and able to meet their nutritional needs through normal diet.

Patients should only be prescribed oral nutritional supplements (ONS) when they cannot meet their daily nutritional requirements from food alone, and following screening have been found to be at risk of malnutrition due to surgical intervention or a disease, disorder or medical condition.⁴ Healthcare professionals are best placed to evaluate whether patients need ONS, and if so, for how long patients should be taking them. Patients who take ONS should be regularly monitored and reviewed and ONS should be discontinued when an individual is no longer malnourished and is able to meet their nutritional needs through normal diet.

Evidence from a number of systematic reviews and studies, including the National Institute for Health and Clinical Excellence (NICE) Guidance [CG32] on Nutrition Support in Adults,⁵ and the NICE Quality Standard [QS24]¹⁸ on Nutrition Support in Adults, show that ONS are a clinically effective way to manage disease-related malnutrition when food alone, however nutritious, is not sufficient to meet a person’s dietary needs. The Managing Adult Malnutrition in the Community pathway, written by a consensus panel of clinical experts, gives guidance on how ONS should be prescribed and used alongside food to manage patients’ health.⁴

Although CCGs up and down the country are quite rightly looking at ways to cut their costs, we are very concerned that certain policies which prohibit or limit the use of oral nutritional supplements (ONS) may have an unintended adverse impact on both patient outcomes and on the overall health and social care economy, potentially causing CCGs greater expenditure in the medium to long term, rather than less.

In the UK, more than 10% of people aged over 65 living in the community are malnourished or at risk of malnutrition.³⁰ Amongst this vulnerable population group, the incidence of chronic age-related diseases is rising. In all care settings, ONS provides a vital lifeline to patients who, without their support, would become or remain malnourished.

When CCGs are looking to reduce their overall expenditure on medicines, it is important to consider the burden of malnutrition in the local health economy, in terms of hospital admissions and re-admissions, and on social care. We believe that ONS play a valid, and very important, role in patient care, as they have significant clinical and health economic benefits. Patients should be prescribed ONS when they cannot meet their daily nutritional requirements from food alone, or are at risk of malnutrition due to a disease, disorder, medical condition or surgical intervention. For example, patients recovering from surgery, those with cancer or those who have had a stroke, may find it difficult to eat because they cannot swallow or digest food properly or because they have lost their appetite, and in such cases, they may need ONS to meet their nutritional requirements, support their recovery and avoid becoming malnourished. We believe that patients who have been clinically screened, and whose treatment plans recommend or require the use of ONS, should all be able to receive the best available care, without undue restriction, for optimal patient outcomes and quality of life.

Oral nutritional supplements (ONS) are a group of products considered as Foods for Special Medical Purposes (FSMPs). Other products falling within the FSMP category may be formulated for a wide range of diseases and medical conditions including metabolic disorders, allergies and gastrointestinal disorders such as Crohn’s Disease. Specialist infant formulae, for medical conditions affecting infants, will also be considered to be FSMPs.

FSMPs are one of the food categories governed by the EU Regulation No 609/2013 for Foods for Specific Groups (FSG), [which also includes infant and follow-on formulae, baby foods and total diet replacements for weight control] and Commission Directive 1999/21/EC on dietary foods for special medical purposes [on 22 February 2019 the latter Directive shall be repealed and replaced by Commission Delegated regulation (EU) 2016/128 supplementing Regulation (EU) No 609/2013].

A FSMP is defined within the FSG Regulation as:

‘a food specially processed or formulated and intended for the dietary management of patients, including infants, to be used under medical supervision; it is intended for the exclusive or partial feeding of patients with a limited, impaired or disturbed capacity to take, digest, absorb, metabolise or excrete ordinary food or certain nutrients contained therein, or metabolites, or with other medially-determined nutrient requirements, whose dietary management cannot be achieved by modification of the normal diet alone’.

FSMPs are classified into three categories within Regulation No 2016/128:

(a) nutritionally complete food with a standard nutrient formulation which, used in accordance with the manufacturer's instructions, may constitute the sole source of nourishment for the persons for whom it is intended;

(b) nutritionally complete food with a nutrient-adapted formulation specific for a disease, disorder or medical condition which, used in accordance with the manufacturer's instructions, may constitute the sole source of nourishment for the persons for whom it is intended;

(c) nutritionally incomplete food with a standard formulation or a nutrient-adapted formulation specific for a disease, disorder or medical condition which is not suitable to be used as the sole source of nourishment.

The food referred to in (a) and (b) may also be used as a partial replacement or as a supplement to the patient's diet.

Oral nutritional supplements (ONS) are distinct from normal foods in that they are designed for patients who are unable - or it is impossible, impractical or unsafe - to eat sufficient quantities of normal foodstuffs to meet their nutritional requirements, or have nutrient requirements which cannot be met by normal food. ONS are essential for the dietary management of those patients who cannot be fed successfully by other means. When ONS are required, the patient should be screened, monitored and advised by a healthcare professional.

Nutritionally complete ONS have a formulation which allows them to be used as a sole source of nutrition over prolonged periods of time. Such feeds must, by definition, have a balance of nutrients at levels capable of supplying all of the patient’s nutritional requirements.

Category (a) products have been designed for the nutritional management of patients suffering from, or at risk of developing, disease related malnutrition. The patients they are intended for may require a higher intake of a whole range of nutrients than the healthy population.

Patients may have become malnourished through prolonged under nutrition, a reduced ability to absorb nutrients or an increased nutrient requirement due to their disease state. Patients may require intakes of nutrients that are higher than the intakes recommended for normal, healthy individuals in order to correct their nutrient deficiencies and maintain their nutritional status. These products are not specifically manufactured for a particular patient type or disease, but for use by a wide variety of patients, and can be used as a sole source of nourishment or as a supplement to the patient’s diet. Certain ONS will fall within the category (a) classification.

Category (b) products are manufactured for specific groups of patients with a particular disease or condition. These patients require a diet that is modified to provide either an increase, or reduction or absence of a specific nutrient, a component of a nutrient, or group of nutrients/components of nutrients. The level of one or more nutrients is modified from the standard formulation levels to reflect the specific requirements of the patients’ disease.

These products are specifically designed for use in patients with a specific medical disorder and can be used as a sole source of nourishment or as a supplement to the patient’s diet. Disease-specific ONS will fall within the category (b) classification.

The range of products falling within Category (c) are diverse and include modular supplements and sip feeds which are not designed to replace foods, but to supplement nutrient or energy intakes from the regular diet to meet the patient’s specific nutritional needs. ONS are less likely to fall within this category because it relates to those products which are not designed to be used as the sole source of nutrition.

Category (c) formulations either:

i) do not provide all of the nutrients required by the patient; or

ii) contain all nutrients required, but not in a balance that would allow them to be used as the sole source of nutrition.

FSMPs are governed by the general food labelling rules, covered by Regulation (EU) No 1169/2011 on the provision of food information to consumers (FIC).³¹ This means that FSMP labels, and hence labels of oral nutritional supplements (ONS), must still comply with the general food labelling rules e.g. on minimum font size for mandatory information like nutrition labelling table, ingredients list etc. but any aspects specifically written into Delegated Regulation EU No 2016/128, take precedence e.g. there are wider rules on nutrition labelling to allow subcomponents of nutrients to be declared that are relevant to the management of the disease. For example, this means that in addition to the mandatory declaration for protein, amino acids can be declared; MCT fat could be declared on an ONS but would not be permitted under the fat declaration of a general food. Sodium must be declared alongside the other minerals contained in ONS but may be repeated alongside the declaration of salt which is mandatory due to FIC. There is no requirement to list percentage RNIs (reference nutrient intakes) on ONS alongside vitamin and mineral declarations.

There are a few instances where the reimbursement authority in the UK (Advisory Committee on Borderline Substances, ACBS) imposes specific labelling requirements, which go beyond the EU labelling rules, before they will accept a product for listing on the Drug Tariff. Since oral nutritional supplements (ONS) are reimbursed, these items must be included on the product label before the ACBS will recommend prescription status. For example, ONS must use the positive statement ‘For enteral use only’ (the label cannot state ‘Not for parenteral use’ or ‘Not for IV use’).To eliminate any risk to patient safety, with a health care professional making an error in feed calculations, the ACBS require electrolyte levels to be declared on pack in mmol, alongside the EU mandatory declaration of mg, with phosphate declared as well as phosphorus.

The Reference Nutrient Intakes (RNIs) are based on Dietary Reference Values (DRVs) which were calculated on the needs of a healthy population, so it is inappropriate to list these values on products formulated to meet the nutritional requirements of patients who are suffering from a disease, disorder, medical condition or those who have recently undergone surgical intervention.

Consumers of oral nutritional supplements (ONS) have different nutritional needs from the normal population. The expression of nutrition information on the energy value and the amount of nutrients of ONS as a percentage of RNIs values as set out in Regulation (EU) No 1169/2011 would be inappropriate and potentially confusing, and could mislead consumers. For this reason, it is not allowed.