This content was published in 2013. We do not recommend that you take any clinical decisions based on this information without first ensuring you have checked the latest guidance.
There is a lot that can be gained from a comprehensive and accurate medication incident report. With this information, it is possible to identify what has gone wrong and put in place systems to prevent it happening again.
Pharmacy management teams can support individuals by providing access and training for local reporting systems and by publishing a list of reportable incidents.
Risk management forms a major part of most, if not all, pharmacists’ jobs — through supporting patients with their medicines, monitoring the prescribing of medicines and supervising dispensing. Although they are often first to identify medication incidents, they can also contribute to mistakes themselves when prescribing, issuing or giving advice on medicines.
It is essential that pharmacists understand why they need to report medication incidents, what can be learnt from them and how to record details properly.
Reasons to report
A key component of safe patient care is to have a strong reporting culture, in which members of staff have an active awareness of the potential for things to go wrong and where reporting incidents is openly encouraged.1 Given the number of incidents that are believed to occur, very few are reported formally (see Figure).
To have a culture that supports learning is also important. Incident reports are vital for identifying what went wrong and to allow organisations to learn from the incident and prevent similar events happening. Incident reporting also flags up certain areas of concern, which can help direct the right resources to where they are needed.
Learning from incident reports takes place locally and nationally. Locally, the reporting of and investigation into a medication incident highlights where systems or standard operating procedures need to improve or where written information or training should be refined.
On a national level, thematic analysis of pooled medication incident reports can be used to identify patterns in the occurrence of incidents, which can then be used to generate patient safety alerts to prevent similar events occurring elsewhere.
When an incident is first identified, there is a range of factors to consider and steps that should be taken to minimise risk to patients.
Assess the patient
Has the medication incident reached a patient? If so, has the patient come to any harm? A doctor should be informed of the incident immediately. The doctor should then review the patient, consider what has occurred and determine if any remedial treatment is required.
Inform the patient
Explain to the patient that he or she has been involved in a medication incident. Although this is usually carried out by the patient’s doctor or a ward manager, more pharmacists are now taking on the responsibility of talking to patients about medication incidents.
Take action to prevent the incident recurring. Although most incidents occur under a unique set of circumstances, when a medication incident has been identified it is often apparent that something needs to be changed urgently. For example, if a standard operating procedure is incorrect and has contributed to an incident then it must be withdrawn immediately. It may be appropriate to restrict prescribing of, or access to, the medicine involved in the incident until a full investigation and implementation of lessons has taken place.
Report the incident
Medication incidents should be recorded as soon as possible after the event so that all relevant information can be obtained. Examples of reportable medication incidents are listed in Box 1.
Box 1: Incidents
Many organisations recommend that the following medication incidents are always reported. This list is not exhaustive and should be tailored to local priorities.
- Incidents involving medicines with a narrow therapeutic index
- Failure to follow antibiotic policy
- Any medication incident that results in patient harm
- Prescribing, dispensing or administering a medicine to which a patient has a known allergy
- Omission of a critical medicine
Inform any staff members who have been involved as soon as possible. They will be able to recall the events leading up to the incident with greater clarity if they do so soon after the event. It also offers the opportunity to reassure staff members that they did not intentionally make a mistake and that it is probable that a colleague, if presented with the same set of circumstances, could make the same error. People who have been involved with medication incidents may suffer a drop in confidence in their work and should be encouraged to discuss the incident with a line manager, mentor or senior colleague.
Recording an incident
All NHS organisations and most pharmacy multiples have their own systems for recording and managing patient safety incidents. Some organisations provide the option of reporting incidents in incident report books; however, many trusts now ask staff to report all incidents using the available electronic system. Electronic incident reporting has many advantages, including fewer mistakes in data entry and the ability to notify many people at once that an incident has been reported. However, it is important to ensure that all staff can access the electronic reporting system — and know how to use it — before incident books are removed from clinical areas.
The National Reporting and Learning System was established in 2003 following a recommendation by the Department of Health.2 All NHS organisations in England and Wales are required to upload their incident reports to the NRLS. Individuals can also report medication incidents directly to the NRLS. Submissions need to contain certain details about the incident reported. This mandatory dataset is often used to set out what information needs to be recorded on incident report forms (see Box 2).
Box 2: Medication incident report form
The type of information required for a medication incident is set out in the National Reporting and Learning Service’s mandatory dataset.1 Most internal reporting systems are based on this dataset and required information normally includes:
- Healthcare setting (eg, acute, mental health, primary care)
- Location of incident (eg, ward, clinic)
- Specialism or service area
- Date and time of incident
- Contributing factors (eg, communication barriers, lack of education and training)
- Description of what happened
- Actions planned or already taken to prevent recurrence
- Patient details (eg, date of birth, gender, ethnicity, disability)
- Severity of harm caused (eg, no harm, low, moderate, severe or death)
- Effect of the incident on the patient (eg, physical, psychological)
Local systems may have additional fields that take into account local priorities and methods of reporting. For example, an acute trust may require staff to indicate when a medication incident involves a Controlled Drug. A summary of the completed incident form can then be forwarded automatically to the trust’s accountable officer for CDs, who should always be informed when such incidents occur.
The most important section of an incident form is the description of what happened, and the person reporting the incident should spend considerable care when completing this section. Although classification codes can be useful in identifying themes, patterns and clusters of incidents, most incidents are unique events and the exact details of the incident can only be obtained through describing the incident.
An accurate narrative will be useful to the person investigating the medication incident, particularly in a large organisation. For example, compare the following descriptions of the same medication incident involving diltiazem:
- Diltiazem was dispensed incorrectly
- The prescription specified that diltiazem MR 180mg once daily was to be dispensed; however, diltiazem MR 120mg tablets were selected by the dispenser. The label on the product read diltiazem MR 180mg once daily. The mistake was not identified during the accuracy check but was noticed by a ward nurse. No tablets were given to the patient
In the latter, more detailed version of the incident the investigator is immediately aware that the patient did not receive the incorrect strength of diltiazem and knows which members of staff were involved in the incident and that the incident was a result of a picking error and not a labelling error.
In an ideal world, all medication incidents would be reported. However, there are many barriers to incident reporting, such as:1
- Fear of blame
- Reports being used out of context
- Lack of resources (eg, time, funding for solution development)
It is good practice for organisations and businesses to maintain a list of medication incidents that should always be reported. At a minimum these should include all never events3 (see Box 3) and any near-miss never events that occur.
Box 3: Never events
A never event is a serious and largely preventable incident that the Department of Health has deemed should never occur provided that the appropriate measures to prevent the incident are in place.
For example, a medication-related never event listed by the DH is the prescription, supply or administration of daily oral methotrexate to a patient for non-cancer treatment (when an error is intercepted before the patient is supplied with the medicine this is not classified a never event but would be a near-miss never event and should be reported).
For more information and a complete up-to-date list of never events visit the DH website.
- National Patient Safety Agency. Seven steps to patient safety. 2004. www.nrls.npsa.nhs.uk (accessed 1 May 2013).
- Department of Health. An organisation with a memory. London: The Department; 2000.
- Department of Health. The “never events” list 2012/2013. January 2012. www.gov.uk (accessed 1 May 2013).