Regulatory Focus™ > News Articles > How Should Regulators Warn Patients About New Drug Risks? UK Wants to Know

How Should Regulators Warn Patients About New Drug Risks? UK Wants to Know

Posted 10 June 2015 | By Michael Mezher 

How Should Regulators Warn Patients About New Drug Risks? UK Wants to Know

In an effort to improve how safety issues are communicated, the UK's Medicines and Healthcare Products Regulatory Agency (MHRA) has launched a survey for healthcare professionals to provide input on how the communications are used.


The survey is being launched as part of the Strengthening Collaboration for Operating Pharmacovigilance in Europe (SCOPE) Joint Action initiative, which was launched to "help medicines regulators operate pharmacovigilance systems" in line with new EU legislative requirements. SCOPE focuses on five specific pharmacovigilance work areas: adverse drug reaction (ADR) collection, signal management, risk communications, quality management systems (QMS) and lifecycle pharmacovigilance.

The primary legal basis for pharmacovigilance requirements in the EU are found in Article 57 of Regulation (EC) No. 726/2004 and Title IX of Directive 2001/83/EC. In 2010 and 2012, the EU introduced new directives and regulations amending its pharmacovigilance requirements, which are collectively known as the new pharmacovigilance legislation.

The Survey

MHRA says the survey will be "used to improve regulatory safety communications" such as direct healthcare professional communications, national regulatory agency communications (such as drug safety updates) and educational materials. These communications are intended to provide healthcare professionals and consumers with information related to drug safety, prescribing changes or ADRs.

In particular, MHRA wants to know how familiar respondents are with each type of communication by supplying examples of each, and whether or not the communications are read or acted upon.

The survey queries respondents about their preferences for electronic and hardcopy communications, and asks that they rate different mediums such as email, social media, text messages and websites for their value in communicating safety updates.

Additionally, the survey asks respondents to quantify how likely they are to take action on a specific safety warning based on different criteria such as the seriousness of an ADR or the ease of implementing a recommendation.



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