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Reports of issues regarding the safety of your medicinal products may come in from many different sources. Most pharmacovigilance professionals expect spontaneous reports to come in from GPs and regulatory authority but there are other sources:
- members of the public
- ‘front line’ healthcare professionals
- ‘non-front line’ healthcare professionals
- Patients themselves
- Regulatory authorities
- Literature Searches
- Your Spontaneous Reporting System
- The media
- Other sources
Additionally, there is no time limit within which problems will come to light: concerns can be raised within a short time of a product’s launch onto the market – or several decades later. It could be that there are issues that only become apparent following extensive searching for safety signals within current and previously existing data.
No matter how a potential or actual safety signal arises, the most important issue is how your company then processes it. You need to do so:
- in a timely manner
- in full compliance with EU pharmacovigilance laws
- in a manner which ensures the best possible outcome for all parties concerned
Dealing with safety signals promptly and correctly, regardless of their source, will lead to the best possible outcome in any given situation, both for you, your product and most importantly your patients.
With the ability to call in a team of senior former-regulators from the EU and elsewhere, Prime Vigilance provides reassurance to your management that products and patients are in the safest of hands. Our consultants have experience in all aspects of emerging safety concerns, from signal evaluation, through risk management, to assistance in preparing for regulatory authority hearings. All that may be needed is a few hours of advice, or there may be extensive involvement, with assistance in preparing responses for the regulatory authorities. The ability to bring top level regulatory and medical expertise – from people who have experience of these problems from “both sides of the table” – can be the difference between make and break for both product and company.
EU Regulations Apply To All Drug Safety Concerns
The European Medicines Agency’s Module XV (‘Safety Communication’) of the Guideline on Good Pharmacovigilance Practices (GVP)1 is a key document dealing with communication and processing of safety issues. It lays out twelve key points on the requirements for the Quality Systems concerned with safety communication. There is an expectation from regulators that the company should be considering communication of this nature:
- throughout all of its risk assessment and risk management procedures
- throughout all of its working procedures
Regulators also expect clear and comprehensive communication between themselves, any public health bodies involved and the Marketing Authorisation Holder (i.e. – your company). Professional advice should be sought to ensure that the right messages are reaching the right audience at the right time according to all the regulations. You also need to ensure that the regulators would consider all communications you issue are considered appropriately formulated for their intended audience.
When presenting information about potential and known risks, you need to include information which is:
- adequately contextualised
- extremely detailed including seriousness, severity, frequency, risk factors, time to onset, reversibility of potential adverse reactions, expected time to recovery – and uncertainties
- comprehensive including information on any competing risks
Regulators will expect particular care to be taken when communication concerns uncertainties. Continual care should be taken to consult with appropriate parties evaluate the effectiveness and appropriateness of communications
- prior to release wherever possible
- following release
- as Safety Concerns are resolved
- as any recommendations are updated
Finally, professional advice should be sought to ensure that all communications comply with data protection legislation.
For comprehensive advice that ensures your communications strategy is always complaint and effective, speak to one of our drug safety experts today. Simply call in complete confidence on +44 (0)1483 307920 for a complete assessment of your company’s needs. Please note professional advice should always be sought on all aspects of safety concerns including compliance with legislation; the overview provided here cannot function as any type of substitute.
1. European Medicines Agency. Guideline. 2012/118465/EMA of 22nd January 2013.
Guideline on good pharmacovigilance practices (GVP). Module XV. Safety communication.
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