Scope

This article aims to help you understand when checks add value to medication processes. The principles within this article are relevant to all areas across primary and secondary care settings.

Embedding an effective checking practice within a process may minimise errors from reaching a patient or service. A check may not always be the most appropriate mechanism to improve safe medicines use.

It is the responsibility of the organisation to assess each step of a medicines process. This article highlights considerations to help support local decision making. It is not possible to define the precise point at which a check adds value to a step in a process as this is dependent on factors unique each organisation.

Excluded from scope

Checking whether something is clinically safe, that is, the clinical or validation check, is outside the scope of this article.

Supervision of trainees is outside the scope of this article.

How a check can reduce harm

A check is designed to detect errors before they reach a patient or service, not prevent them. A check should reduce risk and provide necessary assurance of the quality and safety of the process.

Within a medicine related task, a check is a process where information is examined and cross referenced to ensure the outcome aligns with the instruction or documentation, and vice versa. For example, the medicine name matches the documentation.

Definitions

Checks can be used across all processes in the journey of a medicine, from procurement to administration.

Self (single) check

For the purposes of this article, a self-check is when a person checks and confirms the accuracy of their completed tasks before moving onto the next stage. Sometimes, from an organisational or process view, a single check may be sufficient.

All staff are responsible for ensuring they complete a self-check before progressing to the next stage, even if the next stage is an independent second check by a different person.

Independent second check

An independent second check (sometimes also called a double or second check) is when two people undertake the checking process independently of each other before moving on to the next stage in the process. Both people will separately verify that the information being examined aligns with the documentation or instruction, without knowing the results of their colleague.

To be effective, both checks must be completed independently to prevent those checking being influenced or led by each other.

Considering a single or second check

There are human and system factors to consider when designing a process. Literature describes the benefits of the hierarchy of effectiveness, such as this example from the Patient safety learning hub.

Introducing a check to a process may not be the most effective way to reduce harm or prevent errors. There may be other system focussed interventions in the process design that are more effective and make the error less likely, or easier to identify.

When a check is considered an appropriate intervention from an organisational or process view, either a single check or an independent second check may be appropriate.

Risk assessment

Risk assessment (RA) can be a useful tool to review if a check is the most appropriate intervention, and to assess the type of check required during a medication process.

The medication process should be mapped, and the risk assessed at each stage, including ordering, prescribing, dispensing, administration, and monitoring. It should address both local risks and controls, considering local processes as well as human and system factors. Risk mitigation and uninternded consequences of the use of electronic systems should also be included.

Organisations may have their own risk management policy to support this. See an example of a risk assessment model below.

Any risks, and actions to mitigate them, must be clearly documented. This may require more than one action.

When assessing a process you may wish to review incident data to help identify trends in process failures. Learning from incidents where a process has failed or harm has occurred is described in our Reporting and management of medication incidents and harms page.

Risk assessment model

The following risk assessment model is based on International Council for Harmonisation (ICH) Q9 guidelines for quality risk management. Communication and risk management tools apply throughout all risk management processes.

Risk assessment

• What could go wrong?
• What went or could have gone wrong?
• What might the consequence be?
• How severe would the consequence be?
• How easy would it be to detect?

Risk control

• Is the risk already controlled?
• What should be done to control the risk?
• Can the risk be adequately controlled?

Outputs

• Defined safe working practices, for example standard operating procedures.
• Training and briefing.
• Monitoring plans.

Risk review

• Were the controls effective?
• Are there any new risks? If yes, repeat RA.

Value and limitations of an independent second check

Where an independent second check is deemed to be appropriate, values and limitations are expanded further.

Value of an independent second check

Including an effective independent second check within a medicine-related process may increase opportunities for detecting errors and reduce the risk of harm.

However, it is not practical or feasible to include an independent second check for every step of a process. Situations in which an independent second check may be of more value could include (but are not limited to):

• complex or high-risk medicines
• complex or high-risk situations
• high risk route of administration
• processes completed by new or inexperienced staff
• calculations, even when the calculation is very simple
• any step where a member of staff feels that a check would be beneficial.

Limitations of an independent second check

An independent second check can also have limitations and can bring its own risk if not introduced correctly. Examples of this include:

• practical problems such as extra resource or disruptions in workflow required to carry out checks
• independent second checks not being possible in some scenarios, for example lone workers or remote locations, in which case the practitioner could perform their own independent second check by separating the two checks
• an environment with distractions and interruptions
• false sense of security and presuming someone else will catch the mistake
• variability and inconsistency in how checks are performed
• it being seen as a quick fix for problems in systems or process design.

Implementing a safety intervention

When implementing a new safety intervention such as a check, the conditions or limitations on its use should be clearly communicated so staff are aware of their responsibilities. Use of the check must also be monitored in line with legislative requirements and organisational policy. Good change management processes should be followed, for example the NHS Improving Quality plan, do, study, act (PDSA) learning handbook.

An organisation may choose to increase or decrease the checking requirements for each process or staff group dependent on location-specific factors such as (but not limited to):

• experience level and competence of staff
• types of process being undertaken
• new process or medicine in use
• location of process being undertaken, especially if outside of usual environment.

When possible, the actions of prescribing and dispensing, supply and administration should be performed by separate healthcare professionals. Where there is a risk assessment in place and it is in the best interests of the patient, the same healthcare professional can be responsible for the prescribing and dispensing, supply and administration of medicines. See the Prescribing and dispensing / supply / administration by the same healthcare professional RPS and RCN position statement for more information. It is important to note that these recommendations may need to be adapted to suit the abilities of individual practitioners and indemnity arrangements should be considered. Local standard operating procedures and policies should outline specific details on responsibilities, training, systems of work and processes.

The organisation will need to describe the responsibility and accountability of practitioners and which staff groups can be included in the checking process. The process may include registered and non-registered staff, and may also include the patient. Competence must be assured.

Governance

There are risks associated with all aspects of healthcare. Healthcare providers, including hospitals, accept responsibility for managing these risks through their governance processes. The approach to describing governance arrangements may vary, but should be defined in a local policy.

A formal governance system should clearly define the responsibilities for all staff undertaking processes at all stages of the medicines journey, from procurement to administration. An overarching local policy that includes reference to the key fundamentals is recommended.

The organisation’s policy for checking (and other safety interventions) should specify suitable audits and timetables, along with the reporting mechanism and the responsible committee.

Professional bodies may issue their own guidance for their registrant’s responsibilities regarding safe use of medicines and response to incidents which could be used to support local processes and staff. For example there are Royal Pharmaceutical Society standards for pharmacy professionals in responding to patient safety incidents. Any guidance must be contextualised to reflect different areas of practice, levels of expertise and settings.

Monitoring

Organisations should have processes in place to monitor, review and re-evaluate the implementation of safety interventions, including, but not limited to:

• timetabled audits of compliance with the agreed process
• audits of record keeping and documentation
• monitoring of adverse incidents, including reporting mechanisms and the responsible committee.

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