EMA Clarifies Reporting Requirements for Nonserious Medication Errors

Drugmakers should summarize medication errors that don’t result in adverse reactions in periodic safety update reports and in their risk-management plans, the European Medicines Agency says.

Every effort should be made to include relevant information on these errors, including information made public as single case reports, aggregated data from EU national competent authorities and patient safety groups, the EMA says in draft guidance released April 15.

The guidance draws on recommendations of a 2013 public workshop on medication errors, including the need for data sharing between national regulatory authorities and patient organizations and use of data pooling and analysis to identify medication mistakes. Pharmacovigilance legislation that took effect in 2012 expanded the definition of adverse drug reaction to include medication errors. It also mandated that ADRs be reported to a centralized database called EudraVigilance.

The draft guideline provides detailed information on MedDRA coding of medication errors, both those that cause adverse reactions and those that don’t, following up on error reports and special situations, such as off-label use versus an actual medication error.

The guideline was accompanied by two others: a guideline on risk minimization and prevention of medication errors and an addendum on minimizing risks associated with high-strength and fixed-combination insulin products.

According to the EMA, companies should use a lifecycle approach to reduce the likelihood of medication errors, starting at the drug design stage and continuing through product naming, packaging and labeling. Companies should avoid similar sounding names and ones that incorporate common stems from international nonproprietary names. Drug labeling should describe the drug and proper storage, preparation, dispensing, administration and tracing throughout the supply chain.

Regarding insulin, the EMA wants high-strength and fixed combination products produced in prefilled multidose, disposable insulin pen injection systems. The insulin cartridge should include a safety cap to protect the cartridge, the cartridge holder and the dosing mechanism. Where insulin is available in different strengths in a prefilled pen, the dose steps should be the same for all strengths — i.e., one step corresponds to one unit of insulin at 100 units/ml or 200 units/ml, the EMA says.

Comments on the proposed guidelines are due June 14.

Stay up to date on regulatory stories like this one by subscribing to Drug GMP Report. For over 20 years, drug manufacturers have relied on DGR for the latest on FDA’s interpretation and enforcement of cGMPs and the Quality Systems Regulation — information you need to stay in compliance.