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Memo (for local adaptation) - shortage of supply

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Date:

Re: Shortage of Sodium Bicarbonate Polyfusors (Fresenius Kabi)- all strengths

Description of product affected

Sodium bicarbonate for intravenous infusion is licensed for the treatment of metabolic acidosis and rapid urine alkalinisation. The volume, strength and rate of infusion will depend upon the requirements of individual patients. In less urgent forms of metabolic acidosis, an average dose for adults and older children is 2-5 mmol of bicarbonate per kg bodyweight, given over 4-8 hours. Subsequent doses should be adjusted to the individual patients’ requirements.1

Sodium bicarbonate 1.26% and 1.4% are suitable for peripheral administration. In non-emergencies, concentrations over 1.4% should be given via a central venous access device but in emergencies, higher concentrations (4.2% and 8.4%) may be given peripherally.2

Background

Sodium bicarbonate 1.26%, 1.40%, 2.74% and 8.4% Polyfusors are out of stock stock until late October 2020. The 4.2% Polyfusor will remain available but cannot support an uplift in demand to compensate for other lines. Sodium Bicarbonate 8.4% 100ml bottles (B Braun) and 10ml ampoules (Ethypharm) are available.

Alternative agents and management options

Sodium bicarbonate 8.4% in 100ml bottles (B Braun) is available (insufficient stock of 250ml pack size) as are 10ml ampoules (Ethypharm).

In practice, the 1.26% or 1.4% can be used interchangeably. Trusts should check availability and use whichever of these strengths is in stock. If the prescribed strength is not available, the prescriber should be contacted to amend the prescription. If neither strength is available, sodium bicarbonate 8.4% (bicarbonate 1mmol/mL, sodium 1mmol/mL) may be diluted to prepare lower strength solutions.

To prepare a solution of sodium bicarbonate 1.26%:

1. Add 88mL* of sodium bicarbonate 8.4% to a bag of Glucose 5% 500mL (final volume in bag: 588mL).

2. Mix well by inverting the bag five times.

3. Label bag stating strength and final volume i.e. sodium bicarbonate 1.26%, volume 588mL.

4. Do not mix any other drugs or fluids with sodium bicarbonate solution.

5. Infuse the dose prescribed and discard the rest.

To prepare a solution of sodium bicarbonate 1.4%:

1. Add 100mL* of sodium bicarbonate 8.4% to a bag of Glucose 5% 500mL (final volume in bag: 600mL).

2. Mix well by inverting the bag five times.

3. Label bag stating strength and final volume i.e. sodium bicarbonate 1.4%, volume 600mL.

4. Do not mix any other drugs or fluids with sodium bicarbonate solution.

5. Infuse the dose prescribed and discard the rest.

*The maximum fill addition is 100mL for any 500mL infusion bag in use in the NHS which the Pharmaceutical Aseptic Services Group recommends as guidance to be used by nursing staff working in clinical areas without the need to know the specific limits for an individual infusion bag brand.

The resulting composition of the prepared solution¥ as compared with 1.26% and 1.4% polyfusors is as follows.

|Product |Volume |Content per 100mL |TOTAL content per bag |

| |Sodium

bicarbonate

(g) |Sodium

(mmol) |Bicarbonate (mmol) |Sodium

bicarbonate

(g) |Sodium

(mmol) |Bicarbonate (mmol) | |Sodium bicarbonate 1.26% (Polyfusor) |500mL |1.26 |15 |15 |6.3 |75 |75 | |

Prepared solution¥ | | | | | | | |Sodium bicarbonate 1.26% |588mL |1.26 |14.97 |14.97 |7.4 |88.0 |88.0 | |Sodium bicarbonate 1.4% (Polyfusor) |500mL |1.4 |16.6 |16.6 |7 |83 |83 | |

Prepared solution¥ | | | | | | | |Sodium bicarbonate 1.4% |600mL |1.4 |16.6 |16.6 |8.4 |99.6 |99.6 | |

It should be noted that sodium bicarbonate infusions prepared in glucose 5% have a higher osmolarity (540-570mOsmol/L) than the Polyfusor solution and may be more irritant to the vein, thus it should preferably be administered via a large vein.

Alternatively, sodium bicarbonate can be diluted in sodium chloride 0.9% but the increase in sodium content should be borne in mind as sodium chloride 0.9% 500mL contains 77mmol of sodium and 77mmol of chloride. Avoid diluting with sodium chloride 0.9% in renal impairment due to risk of hypernatraemia.2

For aseptic units who are considering compounding sodium bicarbonate products, an SPS stability assessment is available (log in required):



Acknowledgements

• Dr Virginia Aguado Lorenzo, Senior Pharmacist -Safety Injectable Medicines, Guy's and St Thomas' NHS Foundation Trust

• Fraser Hanks, Principal Pharmacist - Critical Care, Guy's and St Thomas' NHS Foundation Trust

• Craig Rore, Lead Pharmacist, Grampian Medicines Information Centre, Aberdeen Royal Infirmary

References

1. Fresenius Kabi Limited. Sodium Bicarbonate 1.26% solution for infusion. SPC, date of revision of the text12/01/2015, accessed via MHRA, 22nd March 2020:

2. Injectable Medicines Guide (Medusa). Sodium bicarbonate. Monograph, date, 14/05/2019

3. Pharmaceutical Aseptic Services Group, Maximum fill additions to Infusion bags for doses prepared in clinical areas, Version 1: March 2018:

Original document prepared by:

Dr Virginia Aguado Lorenzo, Senior Pharmacist -Safety Injectable Medicines, Guy's and St Thomas' NHS Foundation Trust (memo for local use), adapted by Yuet Wan, London and South East Regional Medicines Information, 23rd March 2019; amended 27th, 02 April 2020 and 20 June 2020, email: medicinesinformation@gstt.nhs.uk

Document modified by:

Name of individual at other centre using the product with modifications, centre, date

For all correspondence please contact:

Name of person at base hospital where memo is circulated (i.e. NOT the original author at Guy’s and St Thomas’ NHS Foundation Trust

Disclaimer: This memo can be adapted for local use. The content does not reflect national guidance. Some of this memo is based on clinical opinion from practitioners. Users should bear this in mind in deciding whether to base their policy on this document. Individual trusts should ensure that procedures for unlicensed medicines are followed where a foreign import drug is required in the interim. Any decision to prescribe off-label must take into account the relevant GMC guidance and NHS Trust governance procedures for unlicensed medicines. Prescribers are advised to pay particular attention to the risks associated with using unlicensed medicines or using a licensed medicine off-label.

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