Welcome to our European Regulatory Roundup, our weekly overview of the top EU regulatory news.

EMA Adopts Batch of Documents Aimed at Preventing Medication Errors

The European Medicines Agency (EMA) has adopted a handful of guidance documents designed to prevent the occurrence of medication errors. In the documents, EMA outlines the best practices for minimizing risk, how to code and assess errors and specific concerns relating to insulin and other diabetes medicines.

EMA has released the documents as part of an attempt to cut the incidence of medication errors, which are estimated to account for between 18.7% and 56% of adverse events among hospitalized patients. The centerpiece of the initiative is a good practice guide on minimizing risk and preventing medication errors. In the 41-page text, EMA discusses the need to consider medication errors across the life cycle of a product, an approach that could lead to the development of safer treatments.

Officials also used the text to outline how the name and design of a product can prevent mix-ups, the need to communicate clearly with patients and healthcare professionals and what corrective actions should follow a medication error. The guidance is supported by a pair of more specialized documents, in which EMA details the process for recording, coding, reporting and assessing errors, as well as specific considerations for high-strength and fixed-combination insulin products.

Each of the texts has advanced quickly. EMA finalized the first drafts of the good practice guides on risk minimization and error reporting, plus the high-strength and fixed-combination insulin-focused addendum, almost exactly one year ago. Since then, the documents have been through multiple rounds of review — 18 distinct steps are listed in the revision history of the risk minimization good practice guide — to reach an agreement on the texts that have now come into force.

EMA has published a pair of shorter, less technical guidance documents to support the adoption of risk-minimization strategies in the treatment of diabetes. The documents address how patients, caregivers and healthcare professionals can prevent medication errors when using two types of diabetes products: high-strength insulins and combinations of insulin and noninsulin active ingredients. The documents list specific recommendations for healthcare professionals and caregivers and patients.

Press Release, Risk Minimization, Coding, High-Strength Insulin, Diabetes Medicines, More   

MHRA Advances Guidance on Human Factors to Promote Patient Safety

The United Kingdom Medicines and Healthcare Products Regulatory Agency (MHRA) has advanced its plan to incorporate human factors into the promotion of patient safety. MHRA is hoping the work will lead to the development of medical devices that are designed to facilitate patient safety.

Members of the Human Factors Task Group met with other interested parties this week to discuss the initiative. At the meeting, the second of four such planned events, the task force decided to divide up the planned guidance on how taking into account the ways in which people use medical devices can facilitate safety. The plan is to split the guidance into four sections, covering pre- and post-approval regulatory considerations, standards and usability.

MHRA is pitching the guidance at manufacturers of medical devices, a group that can make products safer by making good design choices during the development stage. Officials at MHRA think such safe design choices stem from considering how patients will interact with the device. MHRA plans to establish a regulatory process covering the design of development-stage products and surveillance mechanisms for assessing the impact of safety features once a device is on the market.

The task force is looking outside its own walls for feedback on how to go about setting up such systems. At the latest meeting, Dr. Brian Edwards of the Clinical Human Factors Group spoke about the need to collaborate to support good design and patient safety. “It’s important to work together in particular areas where we have overlapping interests such as drug-device combinations,” Edwards said.

MHRA Notice

EMA Sets Out EudraVigilance Coding Best Practices Ahead of ISO Transition

EMA has published best practices for the coding of indications in the eXtended EudraVigilance Medicinal Product Dictionary (XEVMPD). The document is intended to show how coding is handled today, while also supporting the imminent migration to a format established by the International Organization for Standardization (ISO).

Marketing authorization holders (MAHs) currently submit data to EudraVigilance using the MedDRA dictionary, which necessitates the inclusion of a version, level and code for each indication. The plan is to switch to a standard set by ISO. Adoption of an international standard is intended to facilitate the sharing of data, while also giving EMA a way to gather a more detailed picture of each event that is uploaded to EudraVigilance.

The ISO standard supports the coding of detailed demographic information such as age, gender and race. MAHs using the new standard will also gain the option to include details about whether a drug was being used as a second-line treatment or in combination with another therapy. A phased implementation of the ISO standard is set to begin in July, starting with the release of controlled vocabularies and organization identifiers.

Once the phased transition is complete, EMA will drop support for the eXtended EudraVigilance Product Report Message (XEVPRM) format. HL7 SPL, a format based on the ISO identification of medicinal products (IDMP) standard, will take its place. With the transition now approaching, EMA has released the best practice guidance to ensure coding is done today in a consistent way that will make it easier to switch to the ISO standard in the future.

Best Practices

NICE Advocates Personalized Approach to Diabetes Care in Revised Guidance

The United Kingdom National Institute for Health and Care Excellence (NICE) has published revised guidance on the management of Type 2 diabetes. In the guidelines, NICE calls for the use of individualized care regimens that take into account the personal preferences of patients.

NICE is advocating personalized regimens to ensure that the broader health and social care needs of each patient are factored into their treatment. In practice, NICE wants physicians to talk to patients about their HbA1c target and encourage them to achieve it by adapting their diet and lifestyle while adhering to the treatment regimen. The strategy builds on advice in the 2009 guidelines about incorporating dietary advice into diabetes management plans.

Officials at NICE have also updated the treatment pathway to reflect changes in the availability of medicines since the publication of the previous guidance. Physicians are now encouraged to start Type 2 diabetics on a low dose of standard-release metformin. By gradually increasing the dose, NICE thinks physicians can avoid gastrointestinal side effects. If such side effects occur, NICE recommends physicians consider trialing the use of a modified-release metformin. 

The Association of the British Pharmaceutical Industry (ABPI) welcomed the new focus of the guidelines. “Diabetes experts had expressed concerns about the previous guidelines due to their focus on cost over clinical care,” Dr. Jacintha Sivaraja, head of medical affairs at ABPI said. “NICE has addressed these concerns and today’s announcement should encourage clinicians to adopt an individualized approach to treatment, tailored to meet the needs of each patient.”

NICE Release, ABPI Statement

Other News:

EMA has adopted a final guideline on non-clinical local tolerance testing of medicinal products. The guideline, which will come into force in May, outlines how drug developers should approach local tolerance testing on animals. Developers are encouraged to incorporate such tests into toxicology evaluations to reduce the number of animals required. EMA Guideline