Important highlights from pharmacovigilance inspection report

Important highlights from pharmacovigilance inspection report

During a period of one year from 2016 to 2017, the UK GPvP (Good Pharmacovigilance Practice) Inspectorate conducted 36 inspections of marketing authorisation holders (MAHs) and one inspection of a  pharmacovigilance service provider.

The purpose of these inspections was to examine compliance with existing EU and national  pharmacovigilance regulations and guidelines. This report contains data relating to all 37 inspections conducted during the period. 6 critical, 150 major and 84 minor findings were identified. Here are the important highlights of the critical findings:

Signal Management

  • Repeated failure to include all available safety data in signal detection activities, including cumulative ICSR data that resided in the global safety database and non-ICSR literature articles.
  • The MAH had not implemented a process to track safety signals in accordance with GVP Module IX.B.4.1.
  • Incomplete evaluation of a safety signal, where the conclusions drawn (and consequent decisions) from the safety evaluation were not supported by appropriate scientific or clinical justification.
  • Inadequate document control for safety reviews, which resulted in a lack of accurate records to support when reviews had been conducted.

Reference Safety Information (SmPC)

  • Superseded versions of summaries of product characteristics (SmPCs) and patient information leaflets (PILs) being publically available on the MAH’s corporate website. As a consequence of failing to update the website with updated product information, clinically important safety information was not available to patients and healthcare professionals via this route.
  • Failed to maintain the authorised product information

Supervision and Oversight:

Significant failings in the resourcing, oversight and management of the pharmacovigilance system by the MAH such as:

  • No QPPV available
  • MAH not able to gain access to the records/data
  • Inadequate oversight
  • No internal audits of the pharmacovigilance system had been conducted and none were planned
  • No evidence of training for many staff working on pharmacovigilance activities, specifically case processing.

 Non-interventional programmes (incl. patient support programmes PSPs and market research programmes MRPs)

  • No global policy or procedures governing the set-up of PSPs, specifically in relation to the measures to collect suspected adverse reactions from these types of programmes.
  • No mechanism for the global pharmacovigilance function to be able to produce and make available a list of such programmes to support inspection, audit and QPPV oversight.
  • Issues with oversight of PSP vendors, including deficiencies with the pharmacovigilance audit programme and contractual agreements.
  • No measures in place to ensure appropriate set-up of MRPs outside of specific regions, to ensure that suspected adverse reactions are collected from these types of programmes. This included deficiencies with procedural documentation, PSMF content and contractual agreements with third-parties.

System Failure

  • Failed to establish a system to collect and collate safety information from a variety of sources
  • Failed to report serious suspected adverse reactions to the authority
  • Failed to undertake ongoing safety evaluation for the authorised products, and to provide for adequate mechanisms of maintenance and oversight of the pharmacovigilance system.
  • Failed to implement specific quality system procedures and processes for critical pharmacovigilance activities.

Reference to MHRA inspection report:

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