Nobody can deny the fact that COVID-19 has ensured that companies engaged in Pharmacovigilance activities have a well functioning business contingency plan (BCP) in place to ensure work continuity. Thankfully some of the regulatory agencies declared that they have deferred their inspection plans, although some expressed their intention of conducting remote inspections…

What was unusual with this BCP?

• The government mandate to close offices, that resulted in large teams working remotely or from home.
• The practice of social distancing and social isolation
• Potential lack of on-site support when 100% of company personnel work remotely
• Resource issues, especially in companies that still have a ‘desktop’ culture
• Travel Restrictions

The potential impact on Pharmacovigilance

• Compliance associated with expedited reporting of ICSRs, ICSR follow-up, aggregate reports, SDEA/PVA, signal reports, PSMF preparation, etc., Impact on CAPA compliance and other QMS timelines.
• Deferment of Internal and external audit plans. Impact on New and ongoing Pharmacovigilance projects
• Hiring and hand-over process
• Training schedules
• Pharmacovigilance events – Cancellation or Deferment Deferment of regulatory inspections Medicines shortage
• Medical Information – Non-availability of personnel to take calls or to respond to HCP/ non-HCP queries, unless the remote call handling strategy was adopted.
• Travel Restrictions

Contingency Measures

In such situations, one may consider it ideal for raising a planned deviation to document the potential impact. Once the BCP gets revoked, impact assessment and gap analysis need to be undertaken to improve the BCP for future contingency. The COVID-19 situation has been great learning for companies engaged in Pharmacovigilance activities, and this also calls for more robust BCP measures in place.