The Scottish Government

Reason for statement

Local action required

The injection route is more hazardous than other routes of administration and should be reserved for the following circumstances.

• The clinical condition of the patient does not allow administration by another route, for example, oral, naso-gastric, rectal, etc.

• The clinical condition of the patient requires the medicine to be administered by injection to achieve immediate effect and/or the required therapeutic levels.

• The medicine, or a therapeutic equivalent, is unavailable for administration by any other route.

• Administration by injection is in the best interests of the patient.

Policies and systems should be put in place to ensure the following.

• Medicines are only prescribed by injection when no other route is suitable.

• Following local assessments of circumstances and hazards, practitioners who are allowed to prescribe injections are clearly identified. The policies reflect national guidance where available, for example, restrictions relating to the prescribing of cytotoxic chemotherapy. ³⁶

• Prescriptions for injections have a specific finishing date or review date stated. If this is not appropriate, the prescription is reviewed regularly, preferably at least once every 24 hours, by a prescriber in the clinical team, and changed to a less hazardous route at the earliest stage possible.

Formularies and treatment protocols, for example, intravenous to oral step-down policies, should be developed to reflect the need to

• minimise the number of injections administered to patients

• standardise doses or concentrations to avoid complex or unfamiliar preparation processes.

Reason for statement

Local action required

The risk to patients, staff, and the NHS is minimised by using an injection that is ready-to-use, that is, does not require to be further diluted or reconstituted before it is transferred to the administration device. An example would be an ampoule containing the medicine in a liquid form of the required concentration, which only needs to be drawn up into a syringe.

Formularies and treatment protocols should be put in place taking account of the recommendation that, if they are required, injections that are available in a ready-to-use form should be prescribed.

Reason for statement

Local action required

Where injections are presented in a ready-to-use form, that is requiring no further dilution or reconstitution before being transferred to the administration device, and the solution presents no health and safety risks to the operator or to the environment, then the process is low risk and should be carried out in near-patient areas.

This will ensure that the patient receives the medicine at the time that it is required.

Policies and systems should be put in place to ensure the following.

• All ready-to-use injections that pose no health and safety risk to the operator or environment, are transferred to the administration device in near-patient areas.

• All injections transferred to the administration device in near-patient areas are administered immediately.

Reason for statement

Local action required

There are risks of error and contamination associated with the preparation of injections. If injections are not available in a ready-to-use form, or in a ready-to-administer form where required, a risk assessment should be undertaken.

Multi-professional risk assessments should be undertaken to decide the most appropriate location for the preparation of all injections that are not available in a ready-to-use form. The risk assessment process is shown in Appendix 4 and should be incorporated in the local risk management framework.

Risk assessments should be undertaken by

• the organisation

• clinical teams

• individual clinicians in their practice

for

• patient groups

• categories of medicines

• specific situations and circumstances.

Risk assessments should be undertaken for patient groups or categories of medicines to decide general policies. The outcome will depend on local circumstances. For example, some paediatric injections might be assessed as being suitable for preparation in near-patient areas for patients in a paediatric hospital being treated by staff experienced in the calculation and preparation of paediatric doses. On the other hand, in general hospitals with few paediatric beds and fewer staff available with the necessary expertise, the assessment might result in a policy that paediatric injections are prepared in a pharmacy.

Similarly, the preparation of intrathecal injections carries a high risk, and in most circumstances should be undertaken in a pharmacy. However, this may not be possible for operational reasons, for example, anaesthetic practice. In such situations, in environments where intrathecal injections are prepared routinely, it may be appropriate for them to be prepared in near-patient areas by suitably competent practitioners.

Risk assessments should also be undertaken for specific situations and circumstances. For example, an individual patient who is immunocompromised may require injections normally assessed as being suitable for preparation in near-patient areas, to be prepared in a pharmacy.

Policies and systems should be put in place to ensure that injections are prepared by a pharmacy aseptic dispensing service when the preparation of an injection carries a high risk to staff or patients, and it is unavailable from the manufacturer in a ready-to-use form.

Reason for statement

Local action required

Parenteral nutrition solutions that require to be prepared involve complex calculations and manipulation, and have high potential for microbial growth in the final product.

The preparation and/or drawing up of cytotoxic medicines present health and safety hazards to the operator.

Policies and systems should be put in place to ensure that the following injections are supplied from a pharmacy in the final container or device for administration.

• All parenteral nutrition solutions that require to be prepared.

• All cytotoxic injections.

Reason for statement

Local action required

Medication errors during injection preparation occur due to, for example calculation errors, selection of the wrong drug or diluent or, incorrect method of preparation.9,10

Contamination rates are reduced when an injection is prepared by an experienced operator using aseptic technique.25

Policies and systems should be put in place to ensure the following.

• Patients and carers who prepare injections are given appropriate information and instruction (see Appendix 5).

• Only healthcare staff who have completed a competency-based training programme prepare injections. Staff that have completed the training programme are subject

• to a regular re-assessment of competence. The training programme includes, as a minimum, instruction and practice in aseptic technique, in dosage calculation, and in the hazards associated with the preparation of injections. An example of the elements that should be included in a training programme is shown in Appendix 6.

• All required information is available in areas where injections are prepared. The information is up to date, and must conform with the licence holder's Data Sheet, or Summary of Product Characteristics, or the manufacturer's package information.

• It includes, as a minimum where applicable, instruction for reconstitution, compatibility with infusion fluids and other medicines, limits on the concentration of the final solution, stability, and the administration rate.

• Injections are clearly identifiable at all stages during preparation and administration. This may be achieved by labelling the injection, or by another agreed safe system to meet local circumstances and situations.

Trusts should work towards introducing the following.

• Standard operating procedures for the preparation of injections by healthcare staff. An example is shown in Appendix 7.

• Documentation to record all aspects of the preparation of individual injections that are prepared by healthcare staff.

Reason for statement

Local action required

The risk of contamination is far higher when injections are prepared in near-patient areas compared with pharmacy aseptic services facilities, and the risk increases with the complexity of the preparation. Injections prepared in such areas should be administered immediately to reduce the risk of infection. They should not be stored for future use.

Medicines that have undergone reconstitution, dilution or addition may have limited stability, and therefore administration may require to be completed within a specific timescale.

The British National Formulary recommends that the administration of infusions, and other injections requiring slow or intermittent administration, that have been prepared in near-patient areas, should be completed within 12 hours of preparation unless a shorter time period is required due to stability factors.

Policies should be put in place to ensure that administration of injections that have been prepared in near-patient areas

• is commenced immediately following preparation as far as possible

• is completed within 12 hours of preparation unless a shorter period is required due to stability factors.

Medicines should be prescribed by bolus injection wherever possible, and only added to infusions in the following circumstances.

• Constant plasma concentrations are needed.

• A minimum administration time is required.

• A more concentrated solution would be harmful.

• The volume required for a bolus, due to the dose required, is excessive.

Where the above recommendations cannot be adopted for practical or operational reasons, a risk assessment should be undertaken, and the action taken to minimise the risk should be documented.

Reason for statement

Local action required

Regular, planned audit of personnel, environments and procedures involved in the preparation of injections in near-patient areas in healthcare premises must be undertaken to monitor the implementation of, and compliance with, the good practice statements.

The following system should be put in place to audit compliance with the good practice statements.

• Audits of the preparation of injections in near-patient areas in healthcare premises are undertaken every 12 to 18 months.

• Auditors have completed a competency-based training programme, and are subject to regular re-assessment of competence.

• The audits cover personnel, environment, and procedures.

• Observations made during the audits are clearly recorded, and an action plan including timescales for rectifying any deficiencies is agreed. There is a system in place to ensure that any remedial work required is carried out. Contingency arrangements are agreed while deficiencies are being corrected.

Reason for statement

Local action required

Trusts are required ³⁷ to ensure that aseptic dispensing services comply with the standards in the guidance document, Aseptic Dispensing for NHS Patients, 199527 and any subsequent revisions. The standards cover the following elements:

• Process

• Personnel

• Facilities and equipment

• Protective clothing

• Documentation

• Starting materials and components

• Storage and handling

• Labelling

• Product shelf-life

• Quality assurance and release of finished products

• Service audit.

Aseptic dispensing services must be externally audited at least every 12 to 18 months.22

The audits that have been undertaken have identified deficiencies in some aseptic dispensing service facilities, and a national problem with their maintenance.

The following system must be in place to ensure that aseptic dispensing services meet the national standards.

• A corrective action plan with timescales is agreed if the aseptic dispensing service does not meet the required standards. A risk assessment to determine the most appropriate course of action in the interim period is undertaken.

• Auditors have completed a competency-based training programme, and are subject to regular re-assessment of competence.

• Estates services personnel are adequately trained in the planned preventative maintenance of aseptic dispensing service facilities, and ensure that it is given the appropriate degree of priority.