The dispensing service is where the greatest number of adverse events occur in pharmacy, so that is what we will focus on here. However, the processes described can also be applied to other areas of the pharmacy business.

Failure to manage risk leads to consequences: professional, criminal and civil litigation. If you breach your duty of care and this leads to a loss (financial or physical), the person who has been damaged can litigate to recover damages.

If, through your actions or processes, you have transgressed legislation, you can leave yourself open to criminal proceedings. The General Pharmaceutical Council (GPhC), pharmacy’s professional regulator, has a duty to remove registrants from the register if they fall below the expected standards and this includes failure to take reasonable steps to protect the public from risk.

Outside the professional arena, the need to protect members of the public and members of staff is described in a number of pieces of legislation, including The Health and Safety at Work Act, COSSH regulations for hazardous substances and RIDDOR regulations for the reporting of occurrences. If an adverse event occurs, the Health and Safety Executive can investigate and, if a failure to take adequate measures is found, can prosecute under the appropriate piece of legislation. The person who has suffered as a result of the event can also litigate to obtain compensation.

Dispensing errors can lead to litigation by patients who have suffered injury. Professional indemnity insurance is a professional requirement to protect individuals and businesses from such claims and to ensure affected patients can be supported. The GPhC will also take action if a registrant fails to learn from their errors or has failed to take all reasonable steps to ensure that an error does not occur.

The GPhC has confirmed that a ‘single, one-off dispensing error will not constitute cause for a fitness to practice hearing, if there was not a wider pattern of errors or aggravating factors’.¹

Following the Elizabeth Lee case in 2009, it became apparent that criminal proceedings could be taken against a pharmacist following a dispensing error. While there has been a great deal of effort to decriminalise dispensing errors, which has led to substantial progress, there is still potential for criminal proceedings based on the mislabelling of a medicinal product.

A question that should be debated is whether absolute decriminalisation is the right thing for society. At what point does professional negligence become criminal negligence? While we can argue that a single error by a careful pharmacist should not be seen as criminal, should a pharmacist with a cavalier attitude who makes repeated mistakes face criminal proceedings?

Recording and reporting errors

In order to be able to learn from errors, you must record them. Using a local reporting system, you should record errors as well as near misses (i.e. dispensing errors that are found before reaching the patient). The details you should record include the date and time of day the error occurred, who made the error, details of the error and the potential cause of the error.

As part of a dispensing error management process, you should regularly review these errors and near misses and identify the changes in practice you intend to make to avoid a recurrence.

As part of the pharmacy contract in England, pharmacies are required to report errors that did or could have resulted in patient harm to the National Reporting and Learning System (NRLS). This is a useful activity, as the number of dispensing errors that occur within one pharmacy will be too few to draw good conclusions from. By pooling the data from all the pharmacies in England, a more robust analysis of dispensing errors is possible and should lead to a better understanding of risks and, consequently, better recommendations for avoiding risk.

The type of errors reported include:

• Wrong dosage
• Wrong drug
• Formulation
• Wrong quantity
• Wrong patient
• Labelling
• Missing item
• Passed expiry date.

These relative frequencies may not be consistent with your own experience. You might feel that it is more common for an item to be missing or for a patient to receive the wrong quantity as opposed to a patient receiving the wrong dosage or wrong drug. This might be your perception or it might be an under-reporting issue. If this is due to under-reporting, you should ask yourself why some errors are not reported effectively.

One reason that under-reporting may occur is that some errors are seen as less important so they are not reported. This is an assumption that needs to be challenged. If you make a labelling mistake, could it lead to the same consequences (e.g. patient harm and ultimately death) as dispensing the wrong drug?

If an item is missing, could this lead to patient harm if the patient was left without a particular medicine? The under-reporting of some errors is that it results in poor information being available on what actions could be taken to help to reduce risk.