The starting point for proactive pharmacovigilance, the safety specification, summarises what is known and what is not known about the safety of the product.
SAFETY SPECIFICATION
The
starting point for proactive pharmacovigilance, the safety specification,
summarises what is known and what is not known about the safety of the
product. This encompasses the important identified risks and any important
information and outstanding safety questions which warrant further
investigation, in order to refine understanding of benefit:risk during the
post-authorisation period. The epidemiology of the indication is to be
included, together with background incidence rates of events of interest for
further inves-tigation. Additional EU requirements for inclusion in the safety
specification are potential for overdose, potential for transmission of
infectious agents and potential for misuse for illegal purposes. The safety
specification also forms the basis for the risk minimi-sation plan if this is
required.
The
purpose of the pharmacovigilance plan is not to replace but to complement
procedures in place to detect safety signals. For medicines with important
identified risks, important potential risks or important missing information,
additional pharmacovigilance activities to address these concerns should be consid-ered.
The EMEA Guideline describes a range of study designs (e.g., active
surveillance, comparative obser-vational studies) and data sources. An
inventory of European pharmaco-epidemiology centres and health-care databases
is to be created by EMEA to facilitate the implementation of pharmacovigilance
plans.
A
risk minimisation plan is only required in circum-stances where standard
information provision via the medicine’s summary of product characteristics,
patient information leaflet and label is not considered adequate to address
identified safety concerns. Where a risk minimisation plan is considered
necessary, both routine and additional activities are to be included. Some
safety concerns may have more than one risk minimisation activity, each of
which should be eval-uated for effectiveness.
The
need for agreement of risk management plans for new medicines, and when an
unexpected new hazard has been identified, has been rapidly incorporated into
regulatory procedures as a matter of routine. This includes Opinions of the
Committee for Human Medic-inal Products and the Coordinating Group. Around 50
risk management plans were reviewed in the first 6–9 months. The early
experience has suggested a need for appropriate pharmaco-epidemiology and
biostatistics expertise to be available, and this has also been co-opted into
the membership of the Pharmacovigilance Work-ing Party from March 2006. There
has also been discus-sion about wider public access to risk management plans.
To date, this has been limited to isolated exam-ples such as the risk
management plan for lumaricoxib, a
Cox II inhibitor
published in December
2005 (Medicines and
Healthcare Products Regulatory
Agency).
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