EMA Launches Drug Shortage Registry as Part of 'Short Term' Action Plan

| 05 November 2013 | By Alexander Gaffney, RAC, 

Even outside of the United States, drug shortages are proving to be a stubborn problem, and for reasons similar to those causing chronic shortages of essential medications in the US.

Background

In the US, regulators and analysts say no one problem is to blame for ongoing drug shortages, which have hit sterile injectable drugs particularly hard in recent years. Instead, they say, five problems share portions of blame. Among them:

• Some gray market pharmacies have been purchasing drugs experiencing low stock, and then re-selling them at massive markups.
• Government reimbursement policies don't allow for prices to immediately match market demand.
• Low profit margins have caused some companies to cease manufacturing older drugs in favor of newer, higher-profit-margin ones.
• Some companies, and in particular manufacturers of sterile injectables, have experienced quality manufacturing problems.
• overly aggressive inspections by regulators

In response to these challenges, FDA has taken a number of actions intended to mitigate the effects of drug shortages over the course of the last year. Among them:

• allowing the import of certain unapproved drugs to ease especially dire shortage situations
• asking manufacturers to notify FDA of any impending supply problems or disruptions
• working one-on-one with manufacturers experiencing problems
• approving novel manufacturing agreements for some facilities to allow them to release some products for further processing or quality checks-a significant deviation from the usual quality-by-design parameters of current good manufacturing practices (CGMP)
• expediting the reviews of substitute medications
• formulating a strategic plan on drug shortages

Shortages across the Globe

But as it turns out, the US isn't the only place experiencing drug shortages. As Focus has previously reported, Canada has been experiencing severe shortages as well, causing it to accelerate approvals, consider calls for new regulation and policies, and to allow unapproved drugs into the country.

And in the EU, the European Medicines Agency (EMA) has been dealing with drug shortages of its own, ones which mirror many of the issues seen in the US but also reflect the unique political structure of the EU, such as parallel import of medicines from lower-cost countries to those with more economic purchasing power.

But as in the US, the majority of problems seem to be related to quality manufacturing.

In November 2012, EMA sounded the alarm about "product supply shortages" caused by quality manufacturing problems, saying a lack of medicines could harm patients by disrupting treatments or by leading them to less-effective or less-safe alternatives.

In a reflection paper released at the time, EMA observed that global supply chains, a lack of alternatives for some medications, industry's reactive approach to problems and difficulties with coordinating responses with other regulators had all contributed to drug shortages.

Plan to Fight Shortages

EMA laid out a 13-point plan to address the shortages, of which 10 were short-term actions and the rest medium-term.

The first two of those actions were related to establishing catalogues of drug products authorized for use in the EU that have or are experiencing drug shortages. EMA said an internal catalogue of those products would "facilitate future analysis of trends and communication on shortages," while a public catalogue of current shortages would permit the sharing of data amongst EU regulators and the public.

Now, a year after that paper was released, EMA has announced the launch of that public catalogue. In a 4 November 2013 posting on its website, EMA said any medicine in shortage in more than one member state would be contained within the catalogue.

The catalogue will provide information about the reason for the drug shortage, its current status, the extent of the shortage, how patients and healthcare professionals should respond, and provide links to any relevant documents.

FDA currently maintains a similar list on its website which includes information about the company, the product(s) affected, contact information for the company, expected end of the shortage, reason for the shortage and related information.

EMA Announcement

EMA Drug Shortage Catalogue

EMA 2012 Drug Shortage Reflection Paper