Administration of parenteral nutrition without a filter has been associated with a number of adverse incidents including an embolism which resulted in a fatal outcome. Healthcare professionals are advised to use integrated or add-on filters during the administration of parenteral nutrition for patients in all care settings. All parenteral nutrition solutions should be administered via a filter with a pore size no larger than 1.2μm. Where available, it is good practice to administer aqueous/lipid-free parenteral nutrition solutions with a 0.2μm filter.
Advice for Healthcare Providers
- ensure that local protocols include reference to filter use as standard practice when administering parenteral nutrition
- intravenous administration sets and their filters are not compatible with all infusion pumps, this should be considered during the procurement process
- for home care patients , ensure that patients and carers are sufficiently trained in the use of filters if administration sets with integrated filters are not provided
The MHRA undertook a review of guidance associated with filter use during parenteral nutrition administration and identified inconsistencies in recommendations which may result in variability in clinical practice.
Parenteral nutrition refers to the provision of nutrients by the intravenous route and is predominantly used when it is not possible to supply nutrition using the standard gastrointestinal tract route. Parenteral nutrition comprises a solution of nutritional products which may include a combination of amino acids, lipid emulsion, glucose, vitamins, trace elements, electrolytes and water.
Concerns about physicochemical stability, microbial contamination, catheter-related sepsis coupled with high monitoring demands mean that parenteral nutrition is considered a high-risk associated therapy.
Parenteral nutrition products are regulated as medicinal products but may also be made available to meet unmet patient needs as unlicenced, bespoke, variants (known as ‘specials’), or may be prepared in a pharmacy exempt from the requirement to hold a manufacturing licence.
The administration set used to deliver parenteral nutrition may include an integrated in-line filter, but separate add-on filters can also be used.
Following a Regulation 28 Prevention of Future Deaths report, the MHRA undertook a review of the guidance on filter use. It was identified that parenteral nutrition product providers may not issue consistent guidance or may not be consistent with the guidance outlined by the British Pharmaceutical Nutrition Group (BPNG).
Excerpt from the official page. The original is authoritative. Continue reading at UK MHRA ↗