Regulator seeking action on medicines shortages

by Gary Finnegan: The European Medicines Agency (EMA) is coordinating a collective response to the medicines shortages which have plagued several European countries in recent years.

However, the regulator says the first step must be to agree on a harmonised definition of ‘medicine shortages’ so that there is a consensus not only on what measures should be taken when drugs are in short supply, but when to trigger such action.

The Agency hosted a meeting of national regulatory authorities, the pharmaceutical industry, pharmacists and other stakeholders late last year to discuss the development of proactive approaches to preventing shortages in supply and has now produced a report on the issue.

The report features results of a survey conducted among EU Member States which highlights inconsistencies in definitions of ‘shortages’. “This lack of clarity about what a shortage is means that the conditions for reporting shortages differ from one country to another. This makes benchmarking and comparisons very difficult,” it says.

The EMA wants stakeholders to work together to identify the point at which a manufacturing or quality issues is likely to lead to a serious disruption in supply. This should be reported to authorities as early as possible so that contingency plans can be put in place.

“National regulators should agree on common trigger points for notification as well as harmonised data requirements across the EU,” according to the London-based regulator.

It wants to see the development of a European shortages communication network, similar to a rapid alert network, and is urging the pharmaceutical industry to consider ‘stress tests’ to evaluate the effectiveness of measures it has in place to prevent shortages.

The European Association of Hospital Pharmacists (EAHP) says a survey of its members revealed that 86% of hospital pharmacists face medicines shortages at the hospital where they work. Two thirds said shortages are a daily or weekly problem.

This has resulted in delayed or interrupted chemotherapy treatment, heightened risk of Clostridium difficile and deterioration in patients’ condition.

Aida Batista, a board member of the EAHP said agreeing a single definition of medicines shortages could be helpful but was not without its pitfalls.

“It is imperative that the definition is not of a highly restrictive nature. For example, some want to report shortages only if they present a high risk. This will not do. Every medicines shortage causes problems for patients and healthcare professionals, with risks of error contained from substitution to alternatives,” she said.