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Medication Errors: A Pharmacovigilance Overview

Statistics show that approximately 1.5 million prescriptions are written by general practices in the UK on a daily basis and an additional 0.5 million in the hospital setting. It is estimated that up to 2% of patients in UK hospitals are harmed by medication errors.

A recent paper by Makary et al (2016) reported medical errors as the third leading cause of death in the US and is an under-recognised cause of fatalities in other western countries, including the UK and Canada. Errors can occur at an individual level (i.e. human error) or as a result of system failure (i.e. poor procedures and controls).

As a result of the burden associated with medication errors, companies are required to collect information (and where necessary report this information) on mistakes that occur in the process of prescribing, storing, dispensing, preparing or administering their medical products, regardless of the route of administration and whether these mistakes are associated with an adverse event (AE) or not.

As for general AEs, follow up attempts should occur for any medication errors associated with suspected adverse reactions, particularly if medication errors are monitored as a result of a previously identified signal or safety concern or where such errors have the potential to cause serious harm. However, good industry practice would also be to follow up on all medication errors to gain a better understanding of their root cause.

If a medication error occurs in the same patterns or at unacceptably frequencies, or if they result in harm to the patient, it is important for companies to investigate the root causes and investigate what factors contributed to these errors. Where concerns arise companies are expected to proactively work towards implementing appropriate measures or solutions to reduce and where possible prevent errors from reoccurring.

Medication errors are preventable and further harm can be minimised by the continued monitoring of these reports. Where appropriate companies should take action to reduce these risks thereby ensuring their products are used safely and effectively.

The key steps companies should be taking is to ensure the latest guideline on medication errors has been considered within their working practice documents or standard operating procedures. Training will need to be broad and should give staff a clear understanding on how to identify these cases, what information to collect and how to record the data within the PV system.

Professional enquiry handling to support the safe and effective use of your products.
Ease the regulatory burden and keep compliant with current pharmacovigilance legislation.
Product safety through surveillance of published articles and case reports.
Confident staff to support the pharmacovigilance process.
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