Regulatory Focus™ > News Articles > New Emphasis on Reducing Medication Errors to Have Regulatory Implications, Says EMA

New Emphasis on Reducing Medication Errors to Have Regulatory Implications, Says EMA

Posted 04 March 2013 | By Alexander Gaffney, RAC

The European Medicines Agency (EMA) is looking to reduce the number of medication errors that take place in the EU through the formation of a new coordinated approach that could ultimately have regulatory implications, the agency announced.

The proposal, which came out of an EMA workshop held for two days starting 28 February 2013, would specifically seek to improve the reporting of medication errors in the hopes that additional data could prove useful in preventing future errors.

Small Errors, Big Implications

EMA explained in a statement that medication errors are "the single most common preventable cause of adverse events in medication practice and a major public-health burden with an estimated annual cost between EUR 4.5 billion and EUR 21.8 billion."

The errors are far from common, EMA explained. "In Europe, the medication-error rate in primary care is estimated at 7.5% at prescription and 0.08% at the dispensing stage, whereas in the hospital setting the rates vary between 0.3-9.1% and 1.6-2.1% respectively."

Medication errors are different from regular adverse events in that they occur due to mistakes on the part of the user, and not the medicine-so-called "human factors." But some of those errors are ones which have their roots in regulatory issues.

For example, if two medications sound too similar or look too similar to one another, they may be mistaken and given to the incorrect patient. Similarly, if tablet sizes, shapes or colors are too similar for two types of medication that are likely to be taken together, a pharmacist could mix up the two. Those problems could also exist for different doses of the same drug, which may be confused.

By that logic, if regulators with EMA are able to understand that two medications are routinely being mixed up because they look too similar, they might require one of the medications to reformulate its color and shape.

Can't Fix What You Can't See

But therein lies the problem: If regulators don't know about these problems, they can't hope to address them. That's where the 2012 pharmacovigilance legislation comes in, EMA wrote.

"The EU pharmacovigilance legislation provides a clear legal framework for sharing data on medication errors causing harm. Since July 2012, it has required reporting of all suspected adverse drug reactions resulting from medication errors to EudraVigilance, the EU database of adverse drug reactions."

Because medication errors are defined by the agency as a sub-category of adverse events, these will be shared with the agency, and this data "has been demonstrated to result in earlier identification of emerging safety issues, and this can be leveraged to allow medication errors to be prevented through earlier detection of risks."

However, without what EMA called a "close collaboration" between various stakeholders-patient safety authorities, national competent authorities, EMA, the European Commission, patients and healthcare providers-they won't be able to make full use of the data reported to them, or won't get full reporting.

EMA said it soon hopes to develop a harmonized, EU-wide best-practices approach to sharing information and preventing medication errors, to be published through its Pharmacovigilance Risk Assessment Committee (PRAC) at some time in 2013.

Regulatory Focus newsletters

All the biggest regulatory news and happenings.