Managing Public Health Emergency
situations in PharmacoVigilance
I would like touch upon points like What a Pharmacovigilance team supposed to during public health emergency (PHE) situations? If Covid-19 is PHE? What reference do we have for a Pharmacovigilance to effectively manage this PHE?
Is Coronavirus disease
(Covid-19) is a Public Health Emergency?
COVID-19 is a disease caused by a new coronavirus, which has not been previously identified in humans. Coronaviruses are a large family of viruses found in both animals and humans. On 30th January 2020, WHO declared the outbreak of a novel coronavirus (COVID-19) a Public Health Emergency of International Concern. Responding to COVID-19 requires critical preparedness and response which includes equipping healthcare workers (HCWs) and healthcare facility management with the information, procedures, and tools required to safely and effectively work.
What
is Public Health Emergency?
A public health emergency is a public health threat duly recognised either by the World Health Organization (WHO) or the Community in the framework of Decision No. 2119/98/EC of the European Parliament and of the Council.
Is
this Public Health emergencies are applicable to all MAHs or MAHs with relevant
product portfolio?
A public
health emergency is applicable for all MAHs irrespective of their product
portfolio or their treatment products involved in the treatment of current
Covid-19 disease.
Stakeholders communication on requirement of Public Health Emergency?
Pharmacovigilance
requirements for public health emergencies should be considered by the
competent authorities in Member States, the European Commission and the Agency
on a case-by-case basis and appropriately notified to marketing authorisation
holders and the public. The Agency publishes its notifications on the Agency’s
website. Competent authorities in Member States and the Agency should be
adaptable to public health emergencies. Preparedness plans should be developed
as appropriate.
How about Marketing Authorization Holders in Public Health Emergency?
The
pharmacovigilance systems of marketing authorisation holders should be
adaptable to public health emergencies. Any pharmacovigilance system should be
adaptable to public health emergencies and preparedness plans should be
developed as appropriate.
What an MAH shall do during Public health Emergency?
PharmacoVigilance
department shall initiate necessary procedures and implement the necessary
practices in their Quality Management System. Necessary training shall be arranged
to all the MAH staff on awareness, do’s and don’ts. Priorities shall be identified
and documented during this PHE in their Pharmacovigilance system master file. Finally,
a preparedness plan shall be setup to manage the public health emergency in an
efficient manner.
Reference: Refer GVP Module I – Pharmacovigilance systems and their quality systems (see I.C.4. Preparedness planning in the EU for pharmacovigilance in public health emergencies).
