Closed consultation

ACBS policy on standard adult ready-to-drink oral nutritional supplements

Updated 21 May 2021

Applies to England

Please be aware this consultation was originally published on 19 April 2021 but it has been updated. Any comments that had already been made will still be considered, and people who have already commented can do so again. The consultation has been extended to account for the changes and allow sufficient time for consideration.

Introduction

Standard adult readymade (also known as ready-to-drink (RTD)) oral nutritional supplements (ONS) have generally been presented in a standard 200ml volume and in recent years several products in a 125ml volume have also been introduced and accepted by clinicians. However, recently the ACBS has received applications from manufacturers seeking to market other presentation sizes. It has also received applications for standard adult RTD ONS intending to provide a patient’s additional nutritional requirements in a single bottle. This notice provides information about the standard adult RTD ONS presentations that the ACBS is intending to recommend for listing in Part XV of the Drug Tariff and those that it does not consider appropriate for prescribing in NHS primary care. It also provides information for interested parties to make representations to the ACBS about this policy.

Powdered ONS are not within the scope of this notice. Powdered ONS and other categories of borderline substance may be reviewed at a later date.

Pack sizes

The ACBS considers that standard adult RTD ONS presented in pack sizes other than the standard 125ml or 200ml are more likely to confuse prescribers and result in significant prescribing errors. Prescribing errors can have a significant negative impact on patient care and safety as patients for whom an inadequate or excessive volume is prescribed may suffer harm as a result. Incorrect prescribing can also negatively impact the whole healthcare economy by exacerbating malnutrition, increasing likelihood of hospital admission and increasing primary care costs including inappropriate prescribing and the time required for healthcare professionals to correct prescribing errors. For this reason, the ACBS will not recommend any non-standard volume ONS presentations for listing in Part XV of the Drug Tariff and all standard adult RTD ONS products not presented in either 125ml or 200ml will be removed from Part XV.

The ACBS has also concluded that there is no need for the same standard adult RTD ONS product to be presented in more than one volume. The Committee will not accept applications for different volumes of standard adult RTD ONS products already listed in Part XV unless the manufacturer confirms that the new pack size can replace the one that is listed. It would like those manufacturers with multiple presentation sizes of the same product to consider the pack size they would like listed and to inform of those that can be removed.

Adult ONS providing 1kcal/ml

The ACBS considers that standard adult RTD ONS providing 1kcal/ml should only be prescribed for specific clinical conditions. The ACBS understands that standard adult RTD ONS providing 1kcal/ml are sometimes used inappropriately to manage conditions when there is no clinical need. For example, patients that only require a small additional nutritional intake can be advised by a dietitian regarding how to manage their conditions using food. Therefore, the ACBS intends to only recommend these products for the management of intestinal failure.

This excludes 1kcal/ml tube feeds in 500ml, 1000ml and 1500ml presentation sizes, which are required by patients that are enterally fed and have lower calorie requirements.

ONS prescribed for use once per day

In respect of standard adult RTD ONS that are manufactured and marketed with the intention of providing a patient’s additional nutritional requirements in a single bottle, the ACBS has considered that most ONS prescribing guidance focusses on increasing nutritional intake by typically (or approximately) 600kcal per day. Therefore, the ACBS has decided it will only accept such products on the condition they:

• are presented in one of the standardised sizes (125ml or 200ml);
• provide a minimum of 500kcals per bottle; and
• provide all other nutrients in appropriate amounts.

Therefore, the ACBS also intends to remove from Part XV of the Drug Tariff any standard adult RTD ONS products currently marketed for this purpose, if they do not meet the criteria above.

The use of ‘complete’ and ‘fibre’ in brand names and when describing products

We consider that the use of ‘complete’ in the name of a product that is not nutritionally complete to be misleading and could result in the product being used incorrectly. Nutritionally complete products are defined in Article 2 of retained Delegated Regulation (EU) 2016/128 as providing nutrients in such levels that the product may constitute the sole source of nourishment for the persons for whom it is intended. Products that do not meet the definition are not nutritionally complete and, therefore, should not be described as nutritionally complete or use ‘complete’ in the name of a product.

Furthermore, we consider that the use of ‘complete’ in a trademark or brand name appearing on a food or in the presentation or advertising of a food implies a nutrition claim, which is prohibited under Article 7 of those Regulations. Article 7 of retained Delegated Regulation (EU) 2016/128 states ‘Nutrition and health claims shall not be made on food for special medical purposes’.

We take a similar view on the use of ‘fibre’ in the name and/or description of a product. Nutrition claims are only permitted if they are listed in the Annex of retained Regulation (EC) 1924/2006. The Annex lists 2 claims, and the conditions applying to them, that are relevant to the use of ‘fibre’:

• source of fibre: a claim that a food is a source of fibre, and any claim likely to have the same meaning for the consumer, may only be made where the product contains at least 3 g of fibre per 100 g or at least 1.5 g of fibre per 100 kcal

• high fibre: a claim that a food is high in fibre, and any claim likely to have the same meaning for the consumer, may only be made where the product contains at least 6 g of fibre per 100 g or at least 3 g of fibre per 100 kcal

The use of ‘fibre’ in the name or descriptive literature of a product is likely to have the same meaning for the consumer as either of these two claims as it implies a product is either a source of fibre or high in fibre. Products that do not meet the conditions outlined should not be named or described as such.

Process for removing non-eligible products from Part XV of the Drug Tariff

Subject to the following paragraphs, the ACBS intends to ask manufacturers to inform of any products affected by this policy and to make changes accordingly.

In the case of removing non-eligible products, recognising that the ACBS had originally approved the products discussed, it will allow relevant manufacturers to run down existing stock within a reasonable period and they will remain on Part XV of the Drug Tariff for that period. The ACBS Secretariat is willing to speak with manufacturers affected by this policy decision to agree a date by which their stock is likely to be used-up and for the product(s) to be discontinued.

Making representations and publication

Manufacturers, clinicians and other interested parties may make representations about this policy to the ACBS Secretariat by completing and submitting this survey. However, if you have comments on the proposed policy that can more easily be made in a different format, or simply that you would prefer not to make within the format of the online survey, we would be very happy to receive those comments in any format either by post or by email – details are below. The ACBS will consider any responses and may amend the proposed policy accordingly. The final policy, including the ACBS’ considerations to representations, will be published at a suitable time.

ACBS Secretariat
Room 2N03
Quarry House
Leeds
LS2 7UE

acbs@dhsc.gov.uk