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Managing the shortage of Molybdenum-99 / Technetium-99m generators

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Topics: RadiopharmaceuticalsSupply

Supplies are limited till mid-November 2024. Actions and guidance are as provided in National Patient Safety Alert (NatPSA/2024/012/DHSC) issued on 25th October

Developed with stakeholders · This page was development by SPS and DHSC with other colleagues

This page was development jointly by SPS and DHSC with support from Medicine Shortage Response Group; NHS England; national clinical experts in Nuclear Medicine and Radiopharmacy; National Patient Safety Team; Medicine and Healthcare Products Regulatory Agency; and the Devolved Governments.

Contents
  1. Actions
    1. NHS provider Trusts and Health Boards
    2. NHS England and Health Boards
  2. Explanation of the identified safety issue
  3. MHRA guidance
    1. Manufacturing specials units (MS unit)
    2. Section 10 unit
  4. Prioritising patients
    1. Black
    2. Red
    3. Amber
    4. Green
  5. Regional radiopharmacy leads
  6. Bibliography

Actions

To be completed by as soon as possible and no later than the 8th November 2024 for all organisations that handle the radiopharmaceutical Technetium-99m generator.

This is a safety critical and complex National Patient Safety issue with a national alert. Implementation should be co-ordinated by an executive lead (or equivalent role in organisations without executive boards) and supported by clinical leaders in pharmacy and/or radiopharmacy, nuclear medicine, medical physics, cancer services and relevant specialities using radiopharmaceuticals containing Technetium-99m.

NHS provider Trusts and Health Boards

NHS provider trusts and Health Boards in the Devolved Nations with a radiopharmacy unit must:

  • continue to review patient appointment lists to prioritise urgent patients and postpone less urgent patients. Prioritisation categories and criteria are available further down on this page
  • work with your British Nuclear Medicine Society (BNMS) nominated regional radiopharmacy lead to participate in local mutual aid arrangements being led by BNMS and UK Radiopharmacy Group (UKRG)
  • ensure arrangements are in place for patients who may require emergency scans in and out of hours
  • escalate issues to regional teams as needed to ensure timely resolution of problems
  • maintain records of delayed activity and rearranged appointments

NHS England and Health Boards

NHS England will support NHS provider Trusts with the actions, whilst Health Boards should also take on these actions:

  • Regional Chief Pharmacists to assist in coordination of mutual aid arrangements
  • provide an escalation route for patient safety and other risks using existing regional routes
  • escalate issues as needed to DHSC Medicines Supply Team to ensure timely resolution of problems

Explanation of the identified safety issue

There are limited supplies of Molybdenum-99 used to manufacture Technetium-99m generators until mid-November 2024. Technetium-99m is used in diagnostic imaging and procedures, and during some surgeries.

The supply disruption is caused by one of the UK suppliers, Curium, having temporarily ceased all production of generators. Curium is unable to produce:

  • sodium pertechnetate (99mTc) CIS Bio International 2-50 GBq radionuclide generator (previously known as ‘Tekcis’)
  • Ultra-TechneKow FM, 2.15-43.00 GBq, radionuclide generator (UTK)

A second UK supplier, GE Healthcare, also produces Tekcis and UTK Technetium-99m generators and will continue to supply both but is unable to support the increased demand.

To support prioritisation, coordinating hub radiopharmacies will be identified, and the generators produced by GE will be redistributed to these hubs. Radiopharmacies will be asked to supply eluate across the network where appropriate.

Nuclear medicine departments have already received initial guidance from the British Nuclear Medicine Society and review of appointment lists and prioritisation of patients should have commenced. Prioritisation categories and criteria are given below.

Two posts within the Medicines Supply Tool Shortage of Molybdenum99/Technetium-99m generators (Tekcis) and Shortage of Ultra-TechneKow FM [Mo-99]/[Tc-99m] 30.1GBq radionuclide generator (UTK) will be updated with details of any changes to resupply dates and will provide an up-to-date supply overview.

MHRA guidance

MHRA guidance on manufacturing specials units and MHRA section 10 units is relevant in this case.

Manufacturing specials units (MS unit)

The MS unit could supply the eluate against a signed order. A section 10 unit could be asked to dispense the eluate in accordance with a prescription from another hospital pharmacy for a patient of that hospital if the MS holder is part of the same hospital.

The sharing of product licensed technetium generators between Radiopharmacy Units of separate NHS Trusts for the preparation of technetium radiopharmaceuticals would be classed as wholesale and require a wholesale dealers’ licence. Where the MS holder is part of a hospital, they could transfer the generator under the control of the pharmacist in the hospital pharmacy to make the supply so that it is coming from the pharmacy under the guidance on the repeal of section 10(7) of the 1968 Medicines Act.

Section 10 unit

A section 10 unit could be asked to dispense the eluate in accordance with a prescription from another hospital pharmacy for a patient of that hospital. Guidance for pharmacists on the repeal of Section 10(7) is available.

Prioritising patients

Patients should be prioritised for use of available supplies. The British Nuclear Medicine Society and NHS England have defined 4 prioritisation categories.

Regional radiopharmacy leads

Details of regional radiopharmacy leads are available in the medicines supply posts: Shortage of Molybdenum99/Technetium-99m generators (Tekcis) and Shortage of Ultra-TechneKow FM [Mo-99]/[Tc-99m] 30.1GBq radionuclide generator (UTK)

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