• Manoj Swaminathan

Pharmacovigilance, Coding Scenarios and COVID-19

At a time when the world is plagued by the COVID-19 crisis and when there is no approved medicine/ vaccine for managing it, Pharmacovigilance professionals are busy, remotely processing and reporting adverse event reports. In such a situation, it is quite reasonable that one may come across any of the following eleven scenarios:

  1. COVID-19 patients already on company product

  2. COVID-19 patients being treated with company product

  3. Off-Label use of Company Product

  4. Company product being used for diagnosis of COVID-19

  5. Patients on company product exposed to COVID-19

  6. Clinical Studies with Company Product

  7. Adverse Events/ Serious Adverse Events in COVID-19 patients

  8. Serological Tests associated with COVID-19

  9. COVID-19 Vaccine

  10. Patients on company product being quarantined

  11. Compassionate use of company product

Thankfully, in April 2020, a series of terminologies were introduced in an updated version of MedDRA 23.0, and the Pharmacovigilance professionals heaved a sigh of relief, as most of their coding related doubts were answered.

Approximately 70 new COVID-19 related terms were added, and a new HLT 'Coronavirus Infections' was added. The best part was that the following new LLTs were added: Quarantine, Home Quarantine and Home Isolation.

Presently COVID-19 related coding may correspond to either of the following four SOCs:

1. Infections and Infestations

2. Investigations

3. Surgical and Medical Procedures

4. Injury

Besides, the EMA also released a guidance on processing and submission of Individual Case Safety Reports (ICSRs) associated with medicinal products used for the treatment or prevention of COVID-19 infection, where they have focused on the following points:

1. Off-label Use

2. Lack of efficacy (potentially expedited, as COVID-19 may be potentially life threatening). However, there can be situations where off-label use may be associated with lack of efficacy. This may be needed to be dealt differently, if there is no associated ADR

3. Compassionate Use

4. Duplicate ICSRs, including those from literature

5. MedDRA coding guidance

Having said that, COVID-19 continues to keep Pharmacovigilance fraternity busy. It all started with BCP, then extended to the regulatory agencies and even the MSSO. Once things slow down, one can even expect an increase in associated literature reports.

For more information, please refer: https://www.ema.europa.eu/en/documents/regulatory-procedural-guideline/detailed-guidance-icsrs-context-covid-19-validity-coding-icsrs_en.pdf

For more details on the complete list of coding terminologies available, please refer: https://www.meddra.org/covid-19-related-terms-meddra-230-update-spreadsheet