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Proactive pharmacovigilance program of Covid-19 vaccination in haemodialysis centers

European Statement

Patient Safety and Quality Assurance

Author(s)

Carla Pinto, João Godinho, Luzia Fernandes, Patricia Vieira, Isabel Ferreira, Inês Sousa, Carolina Vieira, Ana Sardinha

Why was it done?

To promote a more effective notification process than the spontaneous reporting of suspected adverse drug reactions and contribute to the knowledge of the safety profile of medicines.
Covid-19 vaccines are medicines under additional monitoring, labelled with a black inverted triangle and expected to play a major role in the control of COVID-19 pandemic due to SARS-Cov2 virus.
This new medicine was administrated in a short time period and simultaneously to a large number of individuals in the beginning of vaccination period in Portugal (January 2021), to patients and healthcare professionals of our haemodialysis centers.

What was done?

Development and implementation of a proactive pharmacovigilance program to identify suspected adverse drug reactions (ADRs) to a covid-19 vaccine administration in haemodialysis centers patients and healthcare professionals.

How was it done?

Maintaining spontaneous report for immediate suspected ADRs, pharmaceutical services developed a form to collect suspected ADRs in the following 7 days after each dose administration. It was applied to each vaccinated exactly 7 days after the administration of each dose. To simplify its filling and application, overcoming workload and lack of resources in this pandemic setting, information was displayed with check mark boxes, including the list of described ADRs sorted by frequency, duration intervals and blank space for unexpected reactions.
Due to the large amount and variability of individuals and centers, the form was distributed in paper and online formats and applied to vaccinated patients by doctors or nurses.
Pharmacists validated the forms to notify the national pharmacovigilance system for serious or unexpected ADRs.

What has been achieved?

From the 9469 covid-19 vaccine administrations we obtained 6962 filled forms (74% of vaccinations) from which 38% (2666 forms) had suspected ADRs. 2nd dose had a lower participation rate of about 10%. These participation rates where due to no filled forms in cases of no symptoms.

What next?

Apply this proactive pharmacovigilance model in the integration in the institution of future medicines under additional monitoring will allow better knowledge of occurrence of adverse reactions, improving safety of medicines.
For the best outcomes program must be adapted to each medicine’s specification, considering even simpler tools to obtain information when there are no symptoms to report.

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