Background

The Covid-19 outbreak is a very fast moving situation and updates to this guidance will be made as required.

The British Nuclear Medicine Society (BNMS) has issued guidance to departments for infection prevention and control in nuclear medicine settings during the Covid-19 crisis. The BNMS guidance is updated regularly and can be found on their website:

https://cdn.ymaws.com/www.bnms.org.uk/resource/resmgr/news_&_press_office/news/new_060420_nuclear_medicine_.pdf

This involves ensuring patients who urgently need their Nuclear Medicine scan still get it, whilst at the same time ensuring people who don’t need to come to hospital urgently can stay at home. As a result, both Nuclear Medicine and Radiopharmacy workloads have reduced; many diagnostic studies, including radiolabelled red cells, will not be considered urgent studies. It should be remembered that these studies are postponed not cancelled, and many will still be required once the restrictions currently in place are lifted. Any reduction in workload is therefore temporary and the recovery phase is likely to be very busy. This will require workload to be managed very carefully.

Even with the current reduced workload, there still needs to be a core group of Radiopharmacy staff to ensure that those patients who continue to require their Nuclear Medicine tests urgently are able to have them. The current pandemic will affect Radiopharmacy staffing as staff have to self-isolate as a result of a family member becoming symptomatic, they themselves developing symptoms, or they fall into a high risk group.

This document gives guidance on how the many impacts of the Covid-19 pandemic may be managed.

Infection Control

Departments must comply with local policy and recommendations for prevention of infection. Workflows in the Radiopharmacy should be reviewed so they permit staff to maintain sufficient distance from each other. Access to the Radiopharmacy by nonRadiopharmacy staff (such as drivers and Nuclear Medicine staff collecting radiopharmaceuticals) should be restricted to limit spread of any potential viral contamination. Door handles should be cleaned regularly, and this should be documented. Staff should be instructed to wash their hands regularly, and especially as they are entering the department from outside.

PPE

More infected and potentially infected patients are presenting in hospital, and in order to look after them safely hospital staff are having to wear Personnel Protective Equipment (PPE), and more cleaning materials are required to sanitise staff, facilities and equipment. As PPE and cleaning materials become in increasingly short supply, they may not be available to use in the Radiopharmacy. It is therefore important to develop a strategy for their use, and contingencies to be put in place in the event they are not available.

Any contingencies around PPE and cleaning materials, such as use of non-sterile masks in Grade B clean room for example, must be documented and risk assessed. The local QA Pharmacy specialist should be contacted for advice on this.

Radiopharmacy Service Contingency Plans

In the event there are insufficient staff to run the service, or to rationalise the use of PPE and cleaning materials, contingency plans need to be decided upon and prepared for. Close liaison with neighbouring Radiopharmacies will help with this. The first consideration would be to see if the supply could be outsourced. However, outsourcing arrangements are not as simple as they are when there is a problem with the facility, for example. Then an external Radiopharmacy could reliably provide the service; however in this situation all units are equally as susceptible to staff being unavailable to work and therefore the external Radiopharmacy may be facing the same problems.

One suggested solution would be for Radiopharmacies to work together to consolidate their staffing pool. For example, releasers from neighbouring units could be given local training and be accredited to release within the Quality Management Systems. Radiopharmacy staff in other units could be trained to support a ‘supply hub’ whereby, should there be staffing shortages at any of the units, the workload could be consolidated in one place. The choice of supply hub should take into account location, experience of providing a centralised service and the existence of procedures and systems already in place to support this. Early training should be undertaken to support this proposal and availability of trained drivers must be taken into account. Any contingencies should be risk assessed, and the MHRA should be informed as well as the local HR department.

Another approach could be to revise the roles being carried out by Radiopharmacy staff. Any deviations to usual arrangements for manufacture and independent release must be fully risk assessed and documented, and the MHRA inspector / Regional QA specialist should be informed.

Increasing Pharmacy Aseptic Capacity during the Coronavirus Pandemic

The Covid-19 pandemic has placed increased demand on Pharmacy Aseptics to provide additional services for intensive care wards, for example pre-filled syringes. There may also be a knock on effect on other aseptic services such as oncology, central intravenous additive services (CIVAS) or parenteral nutrition as facilities or staff are reallocated to meet the increasing Covid-19 related demands. Depending on the staffing arrangements in the Radiopharmacy, the reduction in non-urgent workload may mean there is spare capacity (either staffing or within the facility as necessary) which can be used to support other aseptic services in the organisation.

There are two different contingencies which could be put in place to help:

1. Radiopharmacy staff working in other areas of Aseptics.

This is the easiest and most likely scenario, since the main issue affecting capacity is likely to be lack of staff. Local policy for redeployment of staff should be followed if necessary and the following should be considered:

• Firstly the capacity of Radiopharmacy staff should be reviewed to see if staff could be released to train and work in Pharmacy Aseptic Units. This should be regularly monitored to ensure it can continue to be supported – for example, if there is Radiopharmacy staff sickness - so that Radiopharmacy services could still be provided to the required standards. The agreement with the Pharmacy must make it clear what action would be taken in this case; i.e. whether staff would need to be called back to Radiopharmacy or whether the Radiopharmacy service will be reduced according to risk
• Identify training needs of staff with the Aseptic Services Manager. Transferred staff will require training in local aseptic unit procedures and processes. Consideration should be given to the type of clean room facility used in both areas and the impact this may have on training. For example, one area may have Grade B clean rooms whilst another may have Grade D.
• Information on the GMP validation of transferred staff must be provided in advance. This may include:
  • Recent broth tests
  • Environmental monitoring e.g. finger dabs, sessional plates etc.
  • Transfer disinfection qualification
  • Recent competency assessment (where appropriate)
  • Training records (where appropriate)

2. Sharing Radiopharmacy facilities.

This is less likely to be needed, but may be required if the workload in Pharmacy Aseptic Units exceeds the capacity in terms of the number of units which can be made in the workstations available. However, it is more complex than moving the Radiopharmacy staff to the Aseptics department.

Where there is more than one clean room in the Radiopharmacy the best approach would be to designate one room for hosting the guest unit’s processes only. This will have less impact on the Radiopharmacy. Where there are limited clean rooms in the Radiopharmacy this would result in sharing clean rooms and cabinets.

The following should be considered when preparing to share a Radiopharmacy Facility:

• Regulatory arrangements: depending on the organisation these products may be prepared under one of the following two conditions:
  • Under a Section 10 exemption to the Medicines Act 1968 where all preparation is by, or under, the supervision of a Pharmacist.
  • In an MHRA Specials Licensed unit.
  
  Different areas within the organisation may operate under one or other of the above, which needs to be taken into account. For brevity the units will be designated as Section 10 or Licensed.
  
  Where a Radiopharmacy unit has been approached by an Aseptic unit the current MHRA inspector or Regional QA Specialist responsible for their EL (97) 52 audit must be contacted to discuss before proceeding any further. The Aseptic unit must also engage their inspecting entity (MHRA/Regional QA) at the earliest opportunity. Note: all Specials Licensed units must work within the confines of the agreed terms stated by the MHRA in their licence. Once the agreement of the inspector or auditor has been confirmed, the arrangements to be put in place must be documented in the Quality Management System. A change control form will need to be opened which describes how the arrangement is going to be managed, the impact it will have on running the two departments with a suggested time line for this arrangement. Assessment on how much of the workload is transferable should be included in the change control. It may be that not all of it can be done in the Radiopharmacy facility because of specialist equipment.
• A risk assessment must be carried out and should consider the following:
  • Capacity impact on the unit - Defining how workload/capacity issues would be managed is important especially if clean rooms are limited in number.
  • Prevention of cross-contamination to radiopharmaceutical products or aseptic unit products made in the facility. Products should be prepared on a ‘campaign’ basis using appropriate segregation methods so no cross contamination can occur; Radiopharmacy and Aseptic preparation should take place at different times so the product flows are kept separate. Different clean room clothing could be used to differentiate the sessions
• A validation master plan should be drawn up and submitted to the inspector / auditor. Validations already in place should be assessed and further validations carried out for new activity undertaken in the Radiopharmacy and for Aseptics staff working within the unit. Transfer disinfection processes should be risk assessed and adapted as necessary without the need for full validation.
• Staffing requirements and capacity should be considered: for example, whether the work would be undertaken by Radiopharmacy as well as Pharmacy Aseptics staff.
• Clarity on roles and responsibility of staff is required. For example, how staff management will operate, and how deviations or CAPAs, for example, would be reported and managed would need to be agreed.
• A decision needs to be made on whose procedures are going to be followed, and new procedures may be required. Validated procedures that have been demonstrated to be effective in the Radiopharmacy would be required for certain activities in both workstreams, such as gowning and some validation activities. However, Pharmacy Aseptics’ own procedures for aseptic manufacturing or preparation activities must be followed for their work. Should deviation to any procedures be required, these should be documented and approved via a planned deviation.
• Consideration should be given to who is responsible for staff training on how to operate in the new facility. Radiopharmacy staff will need training regarding the interaction of the two work streams.
• Assessment of equipment requirements and availability must be undertaken, for example, whether isolators are negative or positive pressure, or whether cabinets are horizontal or vertical laminar flow. Pre-assembled trays and labels may need to be produced. This may have to be done in Pharmacy if the Radiopharmacy department does not have the facility to do it.
• Radiopharmacy units are highly controlled areas due to the storage and use radioactive substances so, as determined by the Ionising Radiations Regulation (IRR17), access to these units is strictly limited to designated staff with appropriate radiation protection training. The RPA should be consulted regarding the arrangements and the Radiation Protection Supervisor is responsible for ensuring good radiation safety is in place throughout this arrangement.
• Radiation protection issues MUST be considered – for example, whether generators remain in place. All non-radioactive products made within the Radiopharmacy should be monitored for radiation contamination and a record must be kept of this. Guest staff will need to be familiar with the Radiopharmacy’s IRR17 local rules and consideration should be given to developing a specific sub-set of local rules for the proposed arrangement, which all staff would need to sign to confirm they have read and understood.
• Environmental monitoring: which cleaning regimes will be used, who will undertake the cleaning and when will it be done must be agreed, as will how out of specification environmental monitoring results are to be investigated.
• Practicalities on times of each production run need to be discussed.
• Storage: Designated ambient and cold temperature storage of starting materials will be required to maintain segregation of materials to prevent incorrect product selection..
• Waste management from the different activities will also need to be segregated. Pharmacy waste streams may follow different internal waste processes.
• A technical agreement needs to be put in place which defines the detailed plans and agreed processes. It will be signed by the heads of section for the units involved and the Chief Pharmacist. The agreement should include the duration of the arrangement and circumstances where an extension of this arrangement is permissible. If the two departments belong to two different legal entities e.g. different hospital trusts – detailed service level, as well as technical, agreements would be expected by the supervising body (MHRA/Regional QA) and would need to be signed by the Chief Pharmacists in both organisations

Input from Rob Lowe, Annika Boloz, Clint Waight and Clint Zvavamwe, Peter Bartholomew, Phil Hillel, Bev Ellis and Jilly Croasdale